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	Pain (1994)
Date of Event	12/28/2018
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, via the manufacturer¿s representative, regarding a patient implanted for a stage 1 trial evaluation.It was reported that the insulation on the lead separated from the lead at the extension connector site.Specifically, when they went to exchange the extension for the battery, it was found that the insulation had separated from the lead.The physician felt the patient had likely been pulling on the extension during the trial, thus compromising the lead.As a factor that may have led to the issue, the physician stated concerns for patient compliance and that the patient had been pulling or messing with the lead.No diagnostics or troubleshooting were performed.The physician chose to explant due to patient compliance concerns, an increased risk of infection, and their repeated requests for additional pain medication.No actions/interventions were taken to resolve the issue.The issue was resolved at the time of report.The patient status was noted as ¿alive ¿ no injury¿.There were no further complications reported or anticipated.

• 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: 8212222
• Report Number: 2649622-2019-00088
• Device Sequence Number: 14019843
• Product Code: EZW
• UDI-Device Identifier: 00643169887923
• UDI-Public: 00643169887923
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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: 12/18/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1MR7R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR