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“百多力”伊翠米亞核磁共振植入式心臟去顫器(包括附件)等4張許可證安全警訊
| 發布日期:2021-04-01 | 更新日期:2021-04-01 發布單位:醫療器材及化粧品組

“百多力”伊翠米亞核磁共振植入式心臟去顫器(包括附件)

      “百多力”英培特拉核磁共振植入式心臟去顫器(包括附件)

“百多力”安心可磁振造影植入式心臟去顫器

      “百多力”新安心可磁振造影植入式心臟去顫器

安全警訊

許可證字號:

衛部醫器輸字第028117

衛部醫器輸字第028525

衛部醫器輸字第030619

衛部醫器輸字第032798

產品英文名稱:

BIOTRONIK Itrevia 5 Implantable Defibrillators with a conditional intended use in a MRI environment incl. Accessories

BIOTRONIK Inventra 7 Implantable Defibrillators with a conditional intended use in a MRI environment incl. Accessories

BIOTRONIK Intica Implantable Defibrillator with a conditional intended use in a MRI environment

BIOTRONIK Intica Neo Implantable Defibrillators with a conditional intended use in a MRI environment

受影響規格/型號/批號:

型號

批號

Itrevia 5 DR-T DF-1 ProMRI

61035977, 61035991, 60968261

Itrevia 5 DR-T DF4 ProMRI

60880411, 60945065, 60956618, 60973626, 60965863, 60965853, 61010456, 61027812, 60865801, 60908035, 60940055, 60966113, 60999563, 61031255, 60913857, 60913835, 60977868, 61001357, 60883327, 60945068, 60966110, 60980659, 60982983, 60999553, 60913855, 60913864, 60913863, 60941229, 60859737, 60966098, 60982962, 61009637, 60880447, 60913606, 60914098, 60940035, 60967412, 60982959

Itrevia 5 HF-T QP DF4 IS4 ProMRI

60929719, 60929715

Itrevia 5 VR-T DF4 ProMRI

61037006, 60978539, 60982029, 61038601, 60983271

Itrevia 5 VR-T DX DF-1 ProMRI

60919591, 60919938, 60934224, 60965272, 60975833, 61010101, 61010071, 61002994, 61014529, 61035981, 61035985, 61035990, 61036739, 61038476, 61036745, 61038501, 61036763, 60860698, 60918591, 60919605, 60945883, 60952853, 60954663, 60981178, 60983186, 60991721, 61010072, 61010109, 61013033, 61036743, 61038507, 61038464, 61036755, 61039414, 61037400, 61037411, 60918648, 60919925, 60930964, 60877195, 60956085, 60975421, 60985219, 61020290, 61035964, 61036742, 61038506, 61038467, 60848147, 60862255, 60876679, 60910633, 60954668, 60960531, 60969447, 60982844, 61010103, 61034566, 61037427, 61037430, 60847157, 60856742, 60861477, 60861506, 60935031, 60935032, 60980272, 60983177, 60983148, 60987475, 61003065, 61014515, 61020274, 61036007, 61038509, 61038471, 61037409, 60862256, 60874819, 60910000, 60919636, 60934261, 60934253, 61035966, 61035976, 61036757, 61039429, 60876147, 60876995, 60898392, 60910632, 60910629, 60910018, 60963404, 60942894, 60945885, 60965256, 60975423, 60977775, 60983655, 60991576, 61000041, 61020330, 61020311, 60847717, 60862238, 60920952, 60935033, 60951605, 60952849, 60954687, 60954649, 60956282, 61020283, 61034536, 61036002, 61038513, 61038465, 61036750, 61037418, 61037399, 60912570, 60945867, 60952835, 60960544, 60987495, 60989879, 61009097, 61020339, 61035995, 61038499, 61038500

Inventra 7 VR-T DX DF-1 ProMRI

60934592

Intica 5 DR-T DF-1 ProMRI

60984509

Intica 5 DR-T DF4 ProMRI

84705890, 61019094, 61026469, 61026362, 61041170, 84715221, 84706082, 61019122, 61039187

Intica 5 VR-T DX DF-1 ProMRI

61020604, 61081478, 84752360, 61009864, 61085492, 61088526, 61051354, 61092127, 61049350, 61081473, 61074924, 61010832, 61049420, 61067515, 61082698, 61047380, 84749501

Intica 7 DR-T DF-1 ProMRI

61079385

Intica 7 DR-T DF4 ProMRI

60989255, 60995860, 61053276, 84706071, 61020874, 61028991, 61028995, 61032011, 61029537, 61029665, 61038285, 61038573, 61047215, 61046951, 61052891, 84705877, 84705882, 61030354, 60994966, 61037268, 61024218, 61032009, 61037722, 61037544, 61037543, 61037691, 61037689, 84716506, 61024512, 61042013, 61038300, 61045990, 61049319, 84715550, 60989290, 61001323, 61024906, 61032298, 61037560, 61049315, 61052889, 61030848, 61037563, 61047261, 61052883, 84705892, 84715558, 60994970, 61033583

Intica 7 VR-T DF4 ProMRI

60997939, 60990018, 61056647, 60997776, 61056921, 84707440

Intica 7 VR-T DX DF-1 ProMRI

61028919, 61072329, 60996239, 61019246, 61059533, 61010801, 61030459, 61058995, 60998846, 84739244, 84737550, 84744861, 61041583, 61041558, 60996514, 60998852, 61027999, 60996853, 61031656, 61031659, 61009737, 61073792, 84744863, 61061385, 60990091, 61010770, 61070878, 61070174, 61074935, 84739253, 61009922, 61019232, 61060724, 61061387, 61068790, 61081495, 60997354

發布對象:一般民眾/醫療從業人員/醫療器材專業人員

警訊說明:(回收/矯正原因描述)

原廠發現部分受影響產品可能因鋰沉積(lithium plating存在電池過早耗盡之問題。前述產品植入事件二年後之發生率約為0.0012 %五年後之發生率約為0.17 %原廠尚未接獲相關的嚴重傷害或死亡報告。

國內矯正措施:

經查,國內進口之受影響型號/批號產品301件,台灣百多力有限公司於11038日開始通知客戶並提供建議事項,毋須對已植入產品進行預防性更換,惟應依患者管理建議採取措施。前述矯正措施預計於110331日完成。

廠商聯絡資訊:

公司名稱:台灣百多力有限公司

聯絡電話:02-2545-9680

聯絡人電子郵件:customer.tw@biotronik.com

相關警訊來源(網址)

英國MHRAhttps://mhra-gov.filecamp.com/s/zN45gQ1nzbQyUumv/d

澳洲TGAhttps://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2021-RN-00667-1