MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 3058

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184)

Patient Problem Urinary Retention (2119)

Event Date 10/25/2021

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 patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the day before yesterday they changed the program with medtronic rep and then reported toward the end of the day pt couldn't pee anymore (pt stated it "stopped it completely") so they turned therapy off.Pt stated the ins is intended to help control how many times pt urinates and stated the therapy was working too well.Pt stated when they turned therapy back on "there were no numbers" and it started on program 1 (agent not clear what pt was referring to by this).Pt requested assistance changing program.Pt inquired why therapy turns off when changing programs.Reviewed general overview of therapy and changing programs.Pt changed to program 1, 4.5volts and confirmed feeling stimulation comfortably in bike seat area.Pt stated they could feel in their bladder like they had to pee and wanted to keep therapy at this setting and will monitor symp toms.Pt mentioned next dr's appt.Is november 11th.Agent did not ask about the circumstances that led to the reported issue.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 12737014
• MDR Text Key: 279556629
• Report Number: 3004209178-2021-16265
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2021

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: 01/14/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/02/2021
• Date Device Manufactured: 07/15/2021
• 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): Other
• Patient Age: 69 YR