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

Model Number	3889-28
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturer¿s representative regarding a patient who was implanted with a neurostimulator.It was reported that the patient¿s lead was noticed to be damaged during the second stage implant of the implantable neurostimulator (ins).It was reported that the lead would not slide properly into the ins and upon further inspection, the doctor noticed that the lead was broken.The lead was removed and a new one was placed.No environmental factors were noted to be related.The issue was reported to be resolved at the time of the report.No patient symptoms were reported.No further complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received and it was reported that the cause of the lead damage was unknown.No further complications were reported.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the tined lead, 3889-28, interstim, us 28 cm (lot#va1ew8u) found the outer insulation of the lead was separated in the body of the lead at a butt joint at the proximal end of the lead; consistent with explant damage.No electrical shorts were identified between the circuits.There was cosmetic blemish on the blue tubing between connector sleeve #0 and #1.Information is provided in the future, a supplemental report will be issued.
Event or Problem Description
No new information.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6952454
• Report Number: 2649622-2017-12784
• Device Sequence Number: 1141877
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1EW8U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/16/2017; 10/25/2017; 11/15/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 10/24/2017; 10/26/2017; 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 98