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

Model Number 3058

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Loss of Power (1475); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Swelling (2091); Complaint, Ill-Defined (2331); Electric Shock (2554); No Information (3190)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor.It was reported that the patient did not have her patient programmer (pp) with her and the ins was zapping her.Patient stated that her reason for calling was to get help with shutting the ins off.Patient confirmed the pp was not lost.Patient stated that she would call back after getting her pp and patient would be walked through turning the device off.No further symptoms or complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was noted that at the time they reported the zapping, they turned their device off.It was reported that they recently fell, on (b)(6) 2018 and has swelling around the battery/incision area.It was stated that the healthcare provider¿s nurse said that it was fine for them to go about their normal activities, even though the device continued to zap them.It was then noted that they were now having pain around their device that started 5-10 minutes ago.It was stated that the device is off and the patient was still getting zapping.They didn¿t know if the device was ¿off or just slightly off.¿ the patient checked and didn¿t see the lightening bolt in the upper left hand corner.It was recommended that they follow up with their healthcare provider to get the area physically checked.Additional information was received from a consumer on (b)(6) 2018.It was reported that the steps taken to resolve the zapping include that the patient shut off the implant, because it was zapping the patient and now they are ok.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

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

Event Description

Patient reported that after the fall the patient started zapping and since then it had been hard to sit or cap down cause patient could feel the battery.Steps taken to resolve the issue were ibuprofen 600 mgs and hot pads and cold press.

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: 7718887
• MDR Text Key: 115408680
• Report Number: 3004209178-2018-16602
• 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: 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• 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: 07/24/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 07/31/2018; 08/22/2018; 08/08/2018
• Supplement Dates FDA Received: 08/13/2018; 09/07/2018; 10/04/2018
• Date Device Manufactured: 01/16/2016
• 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: 29 YR
• Patient Weight: 125