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); Migration or Expulsion of Device (1395); Low Battery (2584); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 05/01/2015

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 a neurostimulator for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient's therapy does not work.Patient also reported that the implant was not working 6 months after it was reported and when they used the controller to change the settings it would not.No further complications were anticipated/noted.

Manufacturer Narrative

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

Event Description

Additional information was received.The patient reported they were unsure if they had turned the ins off the last time they connected or if the ins just depleted.Patient just knew that they had not felt anything since the therapy stopped controlling their symptoms.Patient clarified and it was confirmed the patient had stopped feeling stimulation at that time.Patient stated their symptoms were a little worse than baseline.Patient also reported their ins was floating around in there and didn't sit in one spot.Patient said sometimes the ins stuck out and sometimes it was flat.Patient further stated they could move it around with their hand, like a marble in a bag.Patient thought that the ins was incorrectly installed.There were no falls or traumas associated with the reported events.Patient was redirected to their healthcare provider to assess the ins site and discuss the current symptoms and system issues.Patient also mentioned a loss of symptom control and failure to connect to the ins using their patient programmer.

• 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: 6984377
• MDR Text Key: 91123731
• Report Number: 3004209178-2017-22671
• 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: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

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: 08/28/2015
• 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: 10/26/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 11/08/2017
• Date Device Manufactured: 03/06/2014
• 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: 72 YR