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

Model Number 3058

Device Problems Use of Incorrect Control/Treatment Settings (1126); Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Nerve Damage (1979); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Tract Infection (2120); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor.The patient reported that she was not sure if the interstim was working good enough because she had to keep on changing settings.The patient clarified that the reason she didn't think the interstim was working well enough was because she had a return of urinary symptoms and was having to wear pads.The patient noted that she hadn't been able to get much sleep at night and doesn't go to bed until 11 pm because she is drinking a nutritional supplement called "energize" and had to stop drinking it at a certain time because otherwise she would be going to the bathroom a lot.The patient stated that she was currently on p4 and had already tried all 4 programs.The patient noted that she had worked with a nurse at her healthcare provider¿s (hcp) office in the past for reprogramming assistance, but had not seen her recently.The patient was redirected to follow up with their healthcare provider (hcp) to discuss their concerns with the therapy.No further complications were anticipated/reported.Additional information was received.Caller stated patient needed to go in for reprogramming due to having issues with getting any relief and going back to wearing pads.Caller states the patient was dribbling and had no control.Caller states they had reprogramming done and had 4 new programs put in.Caller stated they were told that the patient only had 4-6 more programs until she tried everything they can.Caller stated since reprogramming, she started experiencing back pain.Caller stated by saturday the pain was more but it was a constant irritant and by sunday the patient had to go to the er.Caller stated patient was experiencing shooting pain in the knee and vaginal area.Caller stated they weren't sure if it was a bladder infection but that the patient couldn't walk and was beveled over.Caller stated hcp determined it was the sciatic nerve that was flared up.Caller stated patient was experiencing shooting pain in her knee and vaginal area but not necessarily in the same place she experienced stim in the past.Caller stated patient's symptoms were improving however after reprogramming.Caller stated patient was disabled and had difficulties telling us what 's going on with her.Caller stated last night she decided to switch the program to p1 but the patient had to go the bathroom like 6 times in an hour and a half.Caller stated they then switched it to p2 and this morning sees a 70% change in the patient's personality and she seemed back to normal behavior.Caller states patient is still on meds but is wondering if all this pain could've been caused by the ins and the reprogramming that was done.Caller states patient doesn't exercise and doesn't do much and does have severe asthma.It was reviewed may feel differently on different programs.Patient could consider turning stim off for a while to see if pain subsides or if hcp says it's ok, to switch to a new program.It was reviewed that the manufacturer does not keep medical records but caller stated she thought patient may be on the mbf program with the canned programs.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Upon further review it has been determined that the code for bladder infection (b)(6) and sciatic nerve damage (b)(6) no longer apply to this event.After reviewing the reported information it can be seen that the patient thought she had bladder infection, but the patient also reported that the hcp determined it was the sciatic nerve that flared up which was causing the issue.Thus, the bladder infection would not be coded for and the code for sciatic nerve damage (b)(6) has been replaced with (b)(6) for pain.As the patient never alleged any nerve damage.If information is provided in the future, a supplemental report will be issued.

• 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: 7688619
• MDR Text Key: 114013208
• Report Number: 3004209178-2018-15776
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/15/2018
• Supplement Dates Manufacturer Received: 07/10/2018; 08/08/2018; 10/05/2018
• Supplement Dates FDA Received: 07/18/2018; 10/03/2018; 10/05/2018
• Date Device Manufactured: 08/21/2015
• 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: 32 YR