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

Model Number 3058

Device Problem Failure to Deliver Energy (1211)

Patient Problems Erythema (1840); Irritation (1941); Pain (1994); Skin Irritation (2076); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that they have been trying to get the device shut off permanently.They said the system hasn¿t done a whole lot for their bladder and really irritates their right leg.They said it started working kind of but they never got the benefit they thought they would.They had brain surgery and the healthcare professional thought it would stimulate the numbness in their leg.Their right side experiences numbness especially on foot and leg and the stimulation hasn¿t helped.Their healthcare professional did not think it was a good idea to remove the system.When they went in it was irritated red and sometimes when they sit down it gets caught.From their hip to foot they get irritation.The patient synced with the ins and it showed 0.0 volts on program 1 and stimulation was off.Patient services explained that stimulation was off and they were not getting therapy.They said they still feel pain.The issue was not resolved through troubleshooting.They patient wanted the device removed.The patient is going to their pcp next week and they will talk to them about getting a surgeon.They said it started not long after implant maybe their second follow up at 3 months.They said if they stayed from diet they were put on they would go back to the way they were before implant.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10483407
• MDR Text Key: 205503010
• Report Number: 3004209178-2020-15253
• 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: 09/02/2020

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: 10/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/02/2020
• Date Device Manufactured: 05/02/2018
• 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): Required Intervention
• Patient Age: 70 YR