MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	3023
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for interstim - other.It was reported that the reason for the call was that the caller wanted to know if the patient programmer needed to be sent back to the manufacturer.Information was reviewed, in that the patient programmer did not need to be sent back.The caller said the patient passed away (no allegation related to device/therapy).They said the device stopped working about two months before the patient passed away.The caller said the patient had a fall, and thought when they fell they "pulled the wire," which was why the device stopped working.
Additional Manufacturer Narrative
Concomitant medical products: product id: 3889-28, lot# v589285, implanted: (b)(6) 2011, product type: lead.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 15-nov-2014, udi#: (b)(4), date of event: date is estimated; month and year are valid.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13544387
• Report Number: 3004209178-2022-02137
• Device Sequence Number: 2214259
• Product Code: EZW
• UDI-Device Identifier: 00613994756558
• UDI-Public: 00613994756558
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2022

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: 12/28/2011
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/16/2022
• Date Device Manufactured: 06/30/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female