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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
Patient Problems Fall (1848); Concussion (2192); Brain Injury (2219); Electric Shock (2554); Insufficient Information (4580)
Event Date 09/08/2015
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 patient who was implanted with an implantable neurostimulator (ins). It was reported that the patient said their ins hadn't worked since date of implant and they couldn't charge their ins and they have not used the system in a long time. The patient said if they get near a tv or radio the wire interacts with the signal. The patient said they were woken up during their implant surgery and they got off of the table and started to kick their health care provider (hcp). The patient moved from wi to co last year and they started to feel shocks and jolts from their ins due to the underground cables. Invisible fences cause the patient to feel shocks. One of the shocks that the patient received caused them to fall off their stool, another caused them tohit their head and it cracked open. The patient said they smashed their head 3 times and they received concussions and has a traumatic brain injury and said it is all due to their ins. The patient said their ins destroyed their spine. The patient wants people to know that ins' do not help a person and they hold medtronic responsible. The patient blames part of their problems on not being woken up during their (b)(6) 2016 surgery. Due to the medical issues that resulted from having a ins they are unable to take medications any longer, the patient specifically mentioned gabapentin. The patient was redirected to their healthcare provider to further address the issue. Additional information was received from the manufacturer representative (rep). The rep was contacted to confirm the information provided by the patient and the rep reported they have no information to provide regarding this event.

 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12269530
MDR Text Key264819393
Report Number3004209178-2021-11846
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2016
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/12/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/03/2021 Patient Sequence Number: 1
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