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

Model Number	3889-28
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the healthcare professional (hcp), via the manufacturer¿s representative, regarding a patient with an implantable neurostimulator (ins).It was reported that the coating of the lead came back, which exposed the coiled wires.As an factor that may have led to the issue, the physician removed and repositioned the lead several times trying to find optimal placement.No troubleshooting was performed.The lead was then removed and replaced.No surgical intervention had occurred and none were planned.The issue was reported as resolved.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
Analysis of the lead with lot number va249ek found that the outer insulation separated at the butt joint of the proximal end due to overstress/damage.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: 9632948
• Report Number: 2649622-2020-02066
• Device Sequence Number: 14238290
• Product Code: EZW
• UDI-Device Identifier: 00643169864436
• UDI-Public: 00643169864436
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 04/21/2020

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: Health Professional
• Device Expiration Date: 11/26/2023
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA249EK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR