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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 Energy Output Problem (1431); Insufficient Information (3190); Patient Device Interaction Problem (4001)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 02/01/2021
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) for unknown indications for use. It was reported that the patient had reprogramming done 3 months ago and she noticed the stimulation is only working on the right leg and too strong when she is laying so she have to turn down stimulation. Patient reported she is not getting stimulation "buzzing" on the left leg but it seems today she maybe feeling little bit of buzzing but she is not sure. The patient was redirected to their healthcare provider to further address the issue. The patient reported that they are scheduled to have their implantable neurostimulator explanted on (b)(6) 2021 for the implantable neurostimulator was "over charged" and they don't use the ins much because the implant was not helping; now the ins was helping their legs but the ins was not helping their feet like it was suppose to do when implanted. When ins was implanted the stimulation was suppose to reach their feet but it did not. Pt had neuropathy on their feet due to chemo and it hurt the pt so bad they couldn't walk. The ins does help with the pts pain at night when it's turned high (patient services understood the stimulation was turned high to help).

 
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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 Key12204470
MDR Text Key262707651
Report Number3004209178-2021-11198
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/21/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/14/2015
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 Received07/19/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/14/2014
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: 07/21/2021 Patient Sequence Number: 1
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