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); Unintended Collision (1429); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Urinary dysfunction/sacral nerve stimulation/gastrointestinal/pelvic floor: product id 3889-28, lot# va0qafg, implanted: (b)(6) 2014, product type lead.

Event Description

A manufacturing representative reported that the patient could not get any stimulation from any of the programs.They ran an impedance test and the only working electrode was 1.It was noted that the patient was in a car accident in (b)(6) 2016 and the device stopped working after that.They programmed the patient on 3+ and 1- and was able to get a stimulation in the right area at a low amplitude.It was recommended that the patient get a revision.The rep further noted they think the patient damaged their lead or their implantable neurostimulator (ins) in the car accident.Pain in the patient's neck and head were reported.Follow up on (b)(6) 2016 indicated that the issue had not been resolved.The ins was indicated for urinary dysfunction/sacral nerve stimulation/gastrointestinal/pelvic floor.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6216862
• MDR Text Key: 63690309
• Report Number: 3004209178-2016-27482
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/31/2016

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: 04/28/2016
• 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: 12/09/2016
• Initial Date FDA Received: 12/31/2016
• Supplement Dates Manufacturer Received: 12/09/2016
• Supplement Dates FDA Received: 09/28/2017
• Date Device Manufactured: 11/08/2014
• 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: 50 YR
• Patient Weight: 75