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

Model Number 3058

Device Problem Battery Problem (2885)

Patient Problem Urinary Retention (2119)

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 consumer regarding a patient who was implanted with an implantable neuro stimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor patient reported that a month ago their healthcare professional told them that their battery was out even though patient was not having any symptoms at the time and so the hcp "tightened i"t and it was still out.The hcp then got a clinician (mdt rep) to meet with the patient who got the battery on and tightened it so hard and they could feel stimulation sensation.Patient stated that on the day of the call, the patient was planning to see their hcp so that he can lower it again so that they can go to the bathroom without waiting and waiting, and it was very difficult to go.No further complications were noted or anticipated.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8206021
• MDR Text Key: 131704832
• Report Number: 3004209178-2018-28514
• 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: 12/31/2018

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: 10/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 12/31/2018
• Date Device Manufactured: 04/19/2018
• 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