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

Model Number 3058

Device Problems Electromagnetic Interference (1194); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Improper Device Output (2953)

Patient Problems Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 12/04/2017

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 a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient was having issues where the implant felt like it was shorting, and they were having pain like they were being zapped.The patient stated that it was still doing it with the ins off.The patient stated they thought they had only lowered amplitude to 0.0v but upon checking the status over the phone, it was confirmed that the ins was off.It was noted that the patient adjusted the day after the issue began.The patient also reported the implant area was swollen and more sore than they were told at the time of implant.The patient stated that at a later time they noticed the ins was coming to the surface and it was getting caught in their chair at work.The patient stated it ¿comes up, gets parallel, and sticks/pokes out a little¿.The patient stated they thought it was rotating, but there was no rotation, and it was right up against the skin and had 45 degrees worth of play.The patient stated they met with their healthcare provider and a representative, and they were told the fat had dissolved in the pocket.The patient noted that they wanted to avoid having to revise or implant it deeper.The patient was redirected to their healthcare provider.Additional information was received on (b)(6) 2018 from the manufacturer representative.It was reported that the shocking pains started around the time that the patient began having problems with their previous programmer.The representative reported that the patient said they had an abdominal mri on (b)(6) and then had a shocking feeling from the inside going down the leg and back.It was resolved by turning off the therapy however when they turned it back on it happened a couple times since then.The representative then later clarified from the patient¿s chart that they had a ct scan and not an mri.It was noted that impedances were normal.There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a patient via a manufacturer¿s representative (rep) indicating that the steps taken to resolve the shocking were that the program was changed on (b)(4) 2018, the date the report was generated.No actions were taken to resolve the ins coming to the surface as the patient indicated that they would not be taking any surgical action at that time.It was noted that the shocking had been resolved and the ins coming to the surface had not been resolved.No further complications were reported.

• 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: 7491254
• MDR Text Key: 107753627
• Report Number: 3004209178-2018-10266
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2019
• 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: 04/10/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 05/14/2018
• Date Device Manufactured: 09/18/2017
• 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: 43 YR