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

Model Number 3058

Device Problems Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Incontinence (1928); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 09/05/2020

Event Type  malfunction  

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 stimulation and gastrointestinal/pelvic floor therapy.It was reported that ever since the implant, the patient had nothing but problems.The patient will feel like they have to urinate and if they don't go right away, urine runs out of their body.Asked when the issue started and the patient said 2 months ago when they went to 1.6 volts.The patient went to the doctor the day before yesterday (tuesday).They increased stim to 2.5 volts but didn't change program.As of last night, the patient is getting a shock like feeling where stimulator is.Agent did not ask about the circumstances that led to the reported issue.Asked the patient if they tried lowering the stim to see if the shocking feeling goes away.The patient had not.The patient was advised they could try lowering it to see if the sensation of shocking goes away.Asked if the patient had any falls or accidents.The patient said they had fallen today.Patient said they did better with the trial.Patient has a follow up doctor appointment in december.Told them to try lowering the stim and if that doesn't help they should call the doctor to see if they can get in earlier.

• 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: 10808849
• MDR Text Key: 215385174
• Report Number: 3004209178-2020-19558
• 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: 11/09/2020

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: 12/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/09/2020
• Date Device Manufactured: 06/24/2019
• 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