MAUDE Adverse Event Report: FLEXTRONICS INTERNATIONAL INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number	305901
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of medical devices: product id 305901, lot# 60126698, product type screening device.Product id 305901 lot# 60126698, product type screening device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received by a trial patient regarding an external neurostimulator (ens).Patient was not impacted by the event.The provider was performing the basic evaluation (be) on the patient.She went to place the lead and the stylet could not be removed from the lead without stretching the lead.This occurred with 3 leads all with the same lot number.She was finally able to get a lead where the stylet could be removed.Provider tried removing the stylets carefully without stretching the lead.She tried different amounts of pressure but was unsuccessful.The issue was resolved at the time of this report.The products were discarded and replaced.No surgical intervention planned or scheduled.Event was also reported in regulatory report # 8030670-2018-00006 and 8030670-2018-00007.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): FLEXTRONICS INTERNATIONAL; 019 friesacherstrasse 3; althofen
• MDR Report Key: 7944200
• Report Number: 8030670-2018-00008
• Device Sequence Number: 19397004
• Product Code: EZW
• UDI-Device Identifier: 00643169721166
• UDI-Public: 00643169721166
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 02/16/2020
• Device Model Number: 305901
• Device Catalogue Number: 305901
• Device Lot Number: 60126698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR