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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Ambient Noise Problem (2877); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091); Chills (2191); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.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 gastrointestinal/pelvic floor who reported that the patient thought that the ins might have turned on the side or moved, but the patient was not sure.The patient noticed that after going to the chiropractor to treat some unrelated pain they realized that they were not feeling right.The patient indicated that they were noticing more pain and it was getting worse so the patient thought that the chiropractor messed something up.When the patient put their leg down they can barely put weight on their right foot like the nerves around, above, and below the ins are messed up and it is connecting to the patient's lower back.The caller indicated that it kind of felt like when you pull your back out and that it was a very weird pain.When the patient pressed on the area and was moving around the night prior they thought "all the nerves were killing her around this think and it is going down her spine." the patient stopped seeing the chiropractor about 2 months prior, but about 6 weeks prior to the call the pain was getting worse and then 2 weeks prior the patient was tremendously worse.The patient also noted that the implant feels different than it felt before and while it is not red, it feels different under the patient's skin.The caller indicated that there had always been a little puff under the scar, but now it is more pronounced and the area looked like it is shaped differently.Furthermore the patient mentioned that they had not been feeling great lately, but indicated that it could be due to the patient having anxiety.The patient indicated that they have a little cold sweat going on out of the blue and that they just feel off.The patient then indicated that one day when getting an adjustment from the chiropractor they experienced a really bad pain and the chiropractor did therapeutic ultrasounds on their shoulder and "stim therapy on the patient's back.Patient was advised that ultrasound is contraindicated.Patient status is unknown at the time of this report.There were no further complication reported or anticipated.

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: 7706009
• MDR Text Key: 115083950
• Report Number: 3004209178-2018-16248
• 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
• 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: 08/14/2016
• 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: 07/17/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2015
• 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: 46 YR