MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION RESTORE PRIME; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 37701

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.The caller states the pt had a revision at some point and, per the caller's understanding, the revision occurred because the pt's 'handheld wasn't working'.No symptoms were reported.

• Brand Name: RESTORE PRIME
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12387974
• MDR Text Key: 269003003
• Report Number: 2182207-2021-01488
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994842299
• UDI-Public: 00613994842299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 37701
• Device Catalogue Number: 37701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/30/2021
• Date Device Manufactured: 08/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention