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

Model Number	3889-28
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2017
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
The patient was having surgery to go from the advanced evaluation (stage 1) to the stage 2 implantation of battery to the implanted lead.While the physician was sliding the boot away from the lead extension it was noticed that the insulation was pulled back away from the proximal end of the lead where it connects to contacts on the lead's proximal end.The bare wire was exposed, and the insulation would not retract back over the exposed wires.The physician opted to change the lead by explanting the lead used for the advanced evaluation (stage 1) and implanting a new lead, connecting the new lead to an implantable neurostimulator (ins) completing the full implant.The patient had a good therapy result post op with stimulation felt in the vaginal area.Surgical intervention was performed and lead was explanted completely.The lead will be returned.No diagnostics performed because there was nothing to be done.The issue reported was resolve at the time of this report.The patient indicators for use are for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.No further complications were reported/anticipated.
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.
Event or Problem Description
The reported that the cause of the lead being pulled away was unknown.The rep restated that the insulation pulled away from the lead.It was noticed as the surgeon retracted the boot from the lead extension.Product was returned.
Additional Manufacturer Narrative
Analysis of the lead lot number va1l3my revealed that the butt joint of the outer insulation was separated at the proximal end of the lead.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.F information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7079152
• Report Number: 2649622-2017-12886
• Device Sequence Number: 1297891
• Product Code: EZW
• UDI-Device Identifier: 00643169887923
• UDI-Public: 00643169887923
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2018

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: 10/18/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1L3MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 12/18/2017; 01/10/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 12/08/2017; 12/18/2017; 01/29/2018
• 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: 67 YR
• Patient Weight: 91