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

Model Number 3058

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date is approximate with year validity.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for gastrointestinal/pelvic floor.The patient reported that the stimulator was turning itself off.The health care professional (hcp) would then turn it back on, and the patient would feel sore.The patient stated that ever since implant, if their stimulation was set too high that they would feel pinching in the labia.It was noted that the stimulation was comfortable after turning it back down.The patient technical services (pats) agent did not ask about the circumstances that led to the reported issue.Pats documented the reported issue, and it was noted that the lead and stimulator had since been replaced (the lead had been replaced due to the patient's need for full body mri scans.) no further complications were reported at this time.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10833899
• MDR Text Key: 216863296
• Report Number: 3004209178-2020-19905
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: 11/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/12/2020
• Date Device Manufactured: 05/14/2015
• 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 Age: 69 YR