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

Model Number 3058

Device Problems Mechanical Problem (1384); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3037, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Patient reported they were having an upcoming surgery, they were asked if it was device related and did not answer.They wanted to make sure they had a working patient programmer to be able to turn their implant off before the surgery.Patient reported that their stimulator had been turned off prior to their last surgery, but they hadn't been able to get their stimulator back on because the programmer on/off buttons weren't working properly.Patient said that not being able to get their implant to turn back on was a huge issue and that they could have died from and while the implant was off their urine count went up to 600 and it was a bad, bad situation.Patient reported they eventually got the implant to turn back on.The patient said their healthcare provider couldn't get the patient programmer to work, so they called the manufacturer and was told to hit the patient programmer button 4x and that was when the ins turned back on successfully.Patient reported the day prior to report they had a procedure, patient reported the test was for removing blood clots in their legs, but they didn't know the name of it, and they did not turn the ins off for it because they were too scared of not being able to get it to turn back on.The patient had to be pulled out of the procedure because their body went into severe shaking and their legs and hips were shaking.Patient asked if the stimulator not being turned off may have caused this patient reported the manufacturer gave them a malfunctional patient programmer to begin with so they wanted a new replacement, not a refurbished.Patient was sent a new patient programmer to resolve the issue.Patient considered this a sudden change in therapy.The patient mentioned they had shoulder surgery and had trouble getting the patient programmer antenna over the implant.No further complications were reported or anticipated.

Manufacturer Narrative

The patient programmer should be omitted as an applicable component as reported in the original report.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: 8109802
• MDR Text Key: 128561674
• Report Number: 3004209178-2018-26353
• 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,Followup
• Report Date: 12/21/2018

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: 08/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 12/21/2018
• Date Device Manufactured: 02/28/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR