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

Model Number 3058

Device Problems Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Purulent Discharge (1812); Hemorrhage/Bleeding (1888); Staphylococcus Aureus (2058); Twitching (2172); Therapeutic Response, Decreased (2271); Irritability (2421); Electric Shock (2554)

Event Date 05/15/2014

Event Type  Injury  

Event Description

The patient stated the implantable neurostimulator (ins) never worked.He would get the stimulation to where he would barely feel and it would start to increase on its own and then it would start shocking him to the point where his leg would kick out from under him.Patient stated he went on a trip last year and didn't bring his patient programmer (pp) the device was shocking him so bad, after three days he had to go home.After permanent implant, the implant site had blood and puss, and he had a staph infection.Patient stated he went to a new doctor, they did culture on his bladder and found bacteria growth that was agitating his ic.They treated patient for bacteria, and it cleared up his issues.Patient stated the bacteria were the issue all along.Patient wanted to get his device removed so he can get an mri, it didn't work in the first place, and because he no longer needs it.It was noted that the therapy was off.Patient said he currently did not have it on because it did not work and he did not need it.Stimulation was turned off and stopped the shocking sensation.No further patient complications have been reported as a result of this event" in the event description.The patient indicators for use were urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional review indicates information previously reported regarding the staph infection does not apply to this event as it pertains to a previous system.Any additional information received related to this issue will be reported under manufacturer's report #3004209178-2017-11144.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient indicated that they were misdiagnosed, and had a bad bacteria infection with interstitial cystitis.They were put on a maintenance antibiotic.Six months later they seldom have the problem.It was also noted that the patient could adjust the device just right, and in a few days, it would get off constantly.There were no further complications reported as a result of this event.The indications for use were urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.

Manufacturer Narrative

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: 6493178
• MDR Text Key: 72799482
• Report Number: 3004209178-2017-08305
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• Date Device Manufactured: 03/13/2014
• 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: 57 YR
• Patient Weight: 118