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

Model Number	3560030
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	07/03/2020
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 the healthcare professional via the manufacturer representative reporting migration of the extension during the implant procedure.The surgeon had difficulties to catch the connection and had to open in the middle of the back to get the extension.This caused extended surgery time of 25 minutes.The tunneling path was about 20 cm and a dilator tip was used for tunneling.There was no problem with the connection.Three coils of the extension were placed under the post-op bandage/dressing.The coils were still in place once the patient returned after the evaluation.The issue was resolved at the time of this report.The patient was alive with no injury.

• 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: 10338202
• Report Number: 2649622-2020-14478
• Device Sequence Number: 3178340
• Product Code: EZW
• UDI-Device Identifier: 00763000203887
• UDI-Public: 00763000203887
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2020

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: 12/17/2021
• Device Model Number: 3560030
• Device Catalogue Number: 3560030
• Device Lot Number: VA24Q0F
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/29/2020
• 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: 58 YR