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

Model Number 3058

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Prolapse (2475)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient had a prolapse for 12 days and one of the patient¿s healthcare professional (hcp) stated that they had the problem because their device was not working.The family member did not know if that meant the device inside the patient or the programmer.The patient went to the emergency room on the 5th and on the 7th they were seen by their primary physician.They were then seen on the 13th by a specialist and on the 16th the patient was taken to the urgent care.They further stated that the patient had been taken to the urgent care 3 times and was in terrible pain and ¿has that thing that came out and is going in by itself¿.The reporter ¿not know what it is but thinks the part that is going out and in is part of her intestine¿.They were told by the urgent care hpc that the patient needed to be seen by a rectal specialist.The patient¿s primary physic ian was trying to get a referral by the insurance but they were still waiting.The patient¿s managing hcp had not been informed of the issue and it was recommended that they do inform them.The family was redirected to follow up with the hcp to report the issue and resolve the issue.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Patient responded to a letter who had surgery on (b)(6) 2018.The patient doesn't know why the device stopped working, but they had a prolapse and surgery was a result.The steps taken to resolve the device not working and prolapse issue was the patient had anew device sent to them and they had surgery.The patient also said they need to see their healthcare provider (hcp) to check the surgery that they did and program the replacement.No further patient complications have been reported as a result of this 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8189125
• MDR Text Key: 131338994
• Report Number: 3004209178-2018-28186
• 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: P080025
• 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
• Report Date: 03/13/2019

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: 08/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 03/13/2019
• Date Device Manufactured: 02/21/2018
• 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: 85 YR
• Patient Weight: 66