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

Model Number	3560030
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
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 professional (hcp) via a manufacturer representative regarding a patient who undergoing an implant procedure for an advanced evaluation with an external neurostimulator.It was reported that an 3536030 extension was opened by the circulator and given to the surgical tech.Both the 3560030 (incorrect product) and the 3560022 (correct product) were in the room and the incorrect product was opened and used by the mistake.The doctor subsequently attached the extension to a 978b128 lead.The rep saw the hcp tighten the set screw with the hex wrench and proceeded to close the insertion site.The patient was then bandaged and taken to recovery.While reviewing the paperwork immediately after the case, the rep noticed that the incorrect extension had been used during the case.The rep never noticed any issue during the case.The rep notified the doctor and staff immediately and the patient was brought back into the operating room from recovery and the incorrect extension was replaced with the correct one (3660022) without incident.This patient is undergoing an trial for urinary incontinence.The patient was doing very well during the trial and is scheduled for a second stage on the 17th. no symptoms were reported.

• 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: 11445607
• Report Number: 2649622-2021-04572
• Device Sequence Number: 3513426
• Product Code: EZW
• UDI-Device Identifier: 00763000203887
• UDI-Public: 00763000203887
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 12/16/2022
• Device Model Number: 3560030
• Device Catalogue Number: 3560030
• Device Lot Number: VA2B687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/09/2021
• 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: 27 YR