MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of the event was estimated.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that the patient had been having problems related to her ins.The patient stated that she was turning it down because it felt like it was severely jolting and now she turned it back up to where it was originally set because she couldn't get rid of the zapping from the right hip where the ins was located to the left hip and down both legs to the back of her knees.The patient noted that she tried turning it off completely but still couldn't make it from the couch to the bathroom without holding onto something because of the pain she was in.The patient mentioned that she was informed of possible risks of lead wire moving or dislodging when it was implanted, so the patient was thinking that was what was causing the problem.The patient was redirected to her health care professional.There were no further symptoms or complications reported or anticipated.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7713496
• MDR Text Key: 115090067
• Report Number: 3004209178-2018-16404
• Device Sequence Number: 1
• Product Code: EZW
• 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
• 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: 09/14/2013
• 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: 07/20/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 03/22/2012
• 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: 68 YR