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

Model Number 3058

Device Problems Energy Output Problem (1431); Environmental Compatibility Problem (2929); Insufficient Information (3190); Data Problem (3196)

Patient Problems Scar Tissue (2060); Urinary Frequency (2275); Distress (2329)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Event date is estimated; year is valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that¿the reason for the call was that yesterday the patient had surgery because they were bleeding (not alleged to be related to device/therapy).They did stereoscopy and something that started with an "r" and a "p" after it.The procedures were for their kidneys (not alleged to be related to device/therapy).They were under sedation for the procedure.After the procedure, they said something was up with the modulation.Last time they talked to a manufacturer representative, they were on program 1 at 4 point something volts.The representative was not aware of the mri issue.When they used the handset after surgery it said they were in mri mode and down to 0.1 volts.They had not touched the handset since (b)(6) 2021.When asked if the medical staff tried to turn their device off or put it in mri mode, they said they had no idea; the device was back in the room.Last night they were going to the bathroom quite a bit more then normal.The patient was asked when that started, and they replied it was days before the mri mode showed up.They were very upset, yelling, and swearing.They wanted the device removed.They wanted it figured out why the device was in mri mode.Their current setting was program 1 at 0.2 volts and therapy was on.They were not willing to do any adjustments.The issue was not resolved through troubleshooting.The patient asked for a manager and were transferred on the call.The patient's relevant medical history included that they were having another procedure (endoscopy) tomorrow (not alleged to be related to device/therapy).The patient was escalated.They were sedated last night; they said they were on a sedative/lorazepam and did not remember leaving the bed.When they went to use the external devices, the device was in mri mode.They¿did not put the device in mri mode and no one at the hospital was admitting to putting the device in mri mode.The device went from 2.0 volts to 3.0 volts without the patient touching it.They stated the manufacturer could not think all the equipment was good and that the full body mri device came out too quick.They said no one knew how to use the device.They were going to follow up with the doctor and have the device removed.They said they would get scar cream and no one would know they had the device.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 11968373
• MDR Text Key: 255448578
• Report Number: 3004209178-2021-09102
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Date Device Manufactured: 06/17/2020
• 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: 56 YR