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

Model Number 3058

Device Problems Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Fall (1848); Headache (1880); Incontinence (1928); Pain (1994); Seizures (2063); Twitching (2172); Urinary Frequency (2275); Complaint, Ill-Defined (2331)

Event Date 03/31/2017

Event Type  Injury  

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 with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.The patient reported they saw their healthcare provider and their healthcare provider adjusted the device and it was ok for a while, however the patient reported on monday when they were eating at olive garden they started to get a twitch in their back by the device and it went up from there, their fork flew out of their hand.The patient reported on tuesday they had seizure like activity.The patient reported they called their healthcare provider and was directed to turn the stimulation off.The patient had turned the stimulation off, however they received the device for their interstitial cystitis and it really helped, when the stimulation was off the patient was miserable and peeing 20-40 times a day and the interstitial cystitis pain returned.The patient also mentioned they peed on themselves.The patient reported they went to the er and got tested for uti, but was told the symptoms were just a flare up of their disease, interstitial cystitis.The patient also mentioned that since they received the device they had been having migraines, starting at the device area and going up their arm and shoulder, they would fall down and have seizure like activity.The patient was redirected to their healthcare provider.The patient reported they would be scheduled for surgery soon as the person who does scheduling is back, the patient did not know what type of surgery and asked for direction.It was reviewed the type of surgery is a medical decision and they were again redirected to their healthcare provider.The patient reported they had a sudden change in therapy.The patient reported that about a year prior they had their teeth removed due to tmj.Ever since then, they have had a lot of problems.Patient reported the oral surgeon didn't place their jaw correctly, didn't adjust it right.Patient reported this misalignment messes the body from head to spine and they believed because of the misalignment it affected their device.No further complications were reported or anticipated.

• 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: 8320204
• MDR Text Key: 135519644
• Report Number: 3004209178-2019-02715
• 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
• Report Date: 02/08/2019

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: 07/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/08/2019
• Date Device Manufactured: 01/23/2017
• 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): Other
• Patient Age: 39 YR