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

Model Number 3058

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problems Incontinence (1928); Therapeutic Response, Decreased (2271)

Event Date 01/22/2020

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 their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that they did not think that their device had completely worked since implant because they still had to wear pads.With a previous ins they were able to know when they needed to go and make it to the restroom, but now they know when they have to go when they stand up and have a little accident.They turned off their ins for a surgery two months ago, and they turned it back on about two weeks ago.Since turning the device back on they still had not seen much improvement in their symptoms.They were originally programmed on p2 at 3.2v and have increased to p2 at 4.2v.They are unable to increase past that number because they have reached the upper limit.They wanted to change programs but reached the upper limit on each setting" p3 at 0.0v, p4 at 0.0v, p1 at 3.9v.Patient services redirected the patient to their hcp to discuss the upper limit and their symptoms.No further device issue alleged / identified.No further patient symptoms or complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They reported that they were trying to understand in more detail how it worked and they learned a lot, it was just a phone talk.

Manufacturer Narrative

Product id: 3037, serial# unknown, product type: programmer, patient.Method/result/conclusion codes have been updated to reflect the new information.If information is provided in the future, a supplemental report will be issued.

Event Description

Mdr decision updated to not reportable.No additional supplemental reports are required unless additional information received indicates reportable event.

• 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: 10146884
• MDR Text Key: 194926800
• Report Number: 3004209178-2020-10208
• 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,Followup,Followup
• Report Date: 07/20/2020

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: 03/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 07/13/2020; 07/13/2020
• Supplement Dates FDA Received: 07/17/2020; 07/20/2020
• Date Device Manufactured: 09/18/2019
• 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: 82 YR