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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 Migration or Expulsion of Device (1395); Overheating of Device (1437)
Patient Problems Burning Sensation (2146); Discomfort (2330); Malaise (2359); Weight Changes (2607)
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id 37751,serial# (b)(4), product type recharger. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer's representative (rep) via a patient regarding the patient's recharging system.   it was explained that when the recharger was plugged into the wall and the implanted neurostimulator (ins) was being charged, the entire recharging system (including antenna) would get warm and this has been happening for "months". Patient would unplug the recharger from the wall and notice it's warm and then have to let it cool down. Caller stated that patient charges once a week and it typically takes them 4 hours (starting at maybe 30%) despite having full coupling bars for the most part. Caller stated that patient hasn't seen any error codes or messages on the screen and recharging system was in good condition when caller examined it yesterday at patient's reprogramming appointment. Caller didn't check recharging stats from tablet when meeting with patient yesterday. The caller was not with the patient. The caller was redirected to have patient continue to charge normally over the next few weeks and then meet with patient again to review recharging stats. It was reviewed that recharger is an electronic device so it may get somewhat warm during use and the 4 hour average charge time isn't out of the ordinary if coupling is changing and ins is low. It was reviewed recharger may need to be replaced but to simply monitor the issue at this point and check recharging stats first.   the manufacturer representative reported that the burning sensation is uncomfortable. The date of the appointment when the recharging stats were obtained and reviewed was (b)(6) 2021. The recharging stats did not help to identify why recharging is taking 4 hours to complete. The patient is waiting for approval for replacement of the recharging system. Additional information was received. It was reported that for about 2 months when the patient attempted to charge their ins the implant would get hot then the recharger would get hot. When the patient charged the implant it burned. A new recharger was requested.

 
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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 Key12158444
MDR Text Key261800562
Report Number3004209178-2021-10733
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,Followup,Followup,Followup
Report Date 08/20/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/14/2016
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 Received08/16/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/15/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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