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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 053 01 17 002
Date submitted: 10/5/2017
Manufacturer:Boston Scientific
Device Type:Model 3200 S-ICD programmer
Description:The Model 3200 S-ICD programmer is a non-implantable, tablet computer that communicates wirelessly (telemetry) with an implanted S-ICD in order to adjust programmable settings and to collect patient data.
Medical Device Identifier:Model 3200 S-ICD programmers
Reason of Field Safety Corrective Action:The attached letter provides important product performance information regarding the potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD1 to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer
Remedy Action:Boston Scientific is developing software to mitigate this behavior. Until updated software is available, the recommendations in the attached FSN mitigate the risks associated with this behavior.


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NCMDR Update action:
Boston Scientific recommends NO changes to clinical follow-up due to this single event. Specifically, for patients with S-ICD systems:
- Continue using the S-ICD system to detect and treat life-threatening ventricular tachyarrhythmia;
- Keep scheduled LATITUDE™ and/or in clinic follow-ups; and
- Follow the precautions identified in the S-ICD user’s manual when radiation therapy is prescribed.

Furthermore, Boston Scientific does NOT recommend the following:
- Early or off-cycle follow-ups are not recommended. This type of memory corruption cannot be detected, thus additional S-ICD checks do not reduce the potential for this device behavior.
- Prophylactic S-ICD replacement or explant is not recommended. The risks associated with such an additional surgical procedure significantly outweigh the risk of reoccurrence of this device behavior.

Boston Scientific is now releasing programmer software version 4.03 to address this behavior for EMBLEM™ S-ICDs2 and your local Boston Scientific representative will arrange to update your programmer soon. Programmer software for SQ-RX S-ICD3 is being developed and until available, the recommendations for programmer interrogations of SQ-RX S-ICDs are unchanged.

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Swissmedic update action:

Boston Scientific is now releasing programmer software version 4.04 to address these behaviors and your local Boston Scientific representative will arrange to update your programmer soon.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:Swissmedic
Source Ref. Number:Vk_20170110_03
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: (Vk_20170110_03) Boston Scientific.pdf