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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 038 10 18 001
Date submitted: 11/1/2018
Manufacturer:St. Jude Medical Inc.
Device Type:8-Channel Lead for the St. Jude Medical Infinity™ DBS (Deep Brain Stimulation) System
Description:Implantable Pulse Generators
Medical Device Identifier:Model No.: 6172ANS, 6170ANS
Multiple batch & serial numbers (See attached FSN)
UDI: 05415067020635, 05415067030306, 05415067020680, 05415067030320
Reason of Field Safety Corrective Action:As background, Abbott believe that some of the listed leads may contain an electrode that does not conform to their material specification. In total, there have been four (4) reports from (2) centers describing that the most proximal stimulation tip electrode (electrode position 4) appeared lighter than the more distal electrodes when radiographed. There have been no reports of patient harm to date. Further communication with additional details about this action, inclusive of management recommendations for any patients that may have been implanted with an affected lead, will be forthcoming as soon as possible.
Remedy Action:Your Abbott representative will assist you in removing these leads from your account and will facilitate replacing them. We are requesting your support on the removal and return of these leads. The Competent Authorities of the countries impacted by this FSCA have been notified of this activity.


NCMDR Update:
Check the patient management recommendations in the attached letter.
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:NCMDR
Source Ref. Number:86D656E093325, 86D656E093325
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: St. Jude Medical Inc.pdf