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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Loss of Power (1475); Insufficient Information (3190)

Patient Problems Incontinence (1928); Therapeutic Effects, Unexpected (2099); Urinary Frequency (2275); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 06/20/2018

Event Type  malfunction  

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 neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient¿s device was not working.The patient had been having problems with overactive bladder, leakage, and ¿things of that nature¿ since an unrelated revision surgery.Syncing with the programmer showed stimulation was off, so the caller was assisted with turning the therapy on.The patient had initially reported they could not feel stimulation.The patient increased the therapy from 1.2 to 1.5 and confirmed they felt stimulation at a comfortable level.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer (con).It was reported that the device not working and stimulation being off was caused by the device not being turned on after placement in the hospital.The patient was having leakage, accidents, and would wet themselves before making it to the restroom.

Manufacturer Narrative

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

• 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: 7704212
• MDR Text Key: 114726806
• Report Number: 3004209178-2018-16221
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 04/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 08/08/2018
• Supplement Dates FDA Received: 08/21/2018; 10/04/2018
• Date Device Manufactured: 11/07/2017
• 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: 70 YR
• Patient Weight: 91