MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Or Device Fragments Location Unknown (2590)

Patient Problems Headache (1880); Itching Sensation (1943); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Tingling (2171); Complaint, Ill-Defined (2331); Electric Shock (2554); Alteration In Body Temperature (2682)

Event Date 07/29/2013

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6) 2017 crts (b)(4) (con): information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that patient's therapy had not done anything for them since it was implanted.Patient reported that they had burning sensation and tingling in their whole body from head to toe since 2013 and when they turn stimulation up, it created more burning and itching so they turned the stimulation off and never turned it back on.Patient mentioned they would have had the device removed since 2013 however their insurance changed and their healthcare professional no longer took their insurance so they couldn't do anything.On (b)(6) 2018, additional information received from the patient.It was reported that since 2013 the patient had the device implanted and during that time she turned her device off.The patient reported that she turned her device off because when she turns the stimulation up, it sends electrical shocks in her body.From the time it did that, she has not felt right; the patient noted her body started to get hot and had headaches but didn't know why.It was noted that the patient went to her regular healthcare professional (hcp) but nothing was found.The hcp who implanted the device no longer takes her insurance and said she would have to pay out of pocket to see him or get device explanted.The patient's insurance gave her hcp listings but none of the doctors want to explant the device because they did not implant the device.Another hcp listings were offered and sent to the patient.There were no further complications or anticipations reported with this event.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7570243
• MDR Text Key: 110579457
• Report Number: 3004209178-2018-12625
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Report Date: 06/05/2018

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: 10/14/2013
• 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: 06/01/2018
• Initial Date FDA Received: 06/05/2018
• Date Device Manufactured: 04/20/2012
• 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: 49 YR