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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 Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Charging Problem (2892)
Patient Problem Burning Sensation (2146)
Event Date 08/27/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The healthcare professional (hcp) reported through a manufacturer representative that the patient was ¿hospitalized complaining from therapy suspension. ¿ it was stated that after technical evaluation, it was identified that the implantable neurostimulator (ins) had experienced a ¿normal condition of overdischarge originated by a long period without recharger. ¿ an ¿emergency recharge¿ was performed and the ins performed to normal operation. The patient was reeducated regarding the recharge process at that time. The patient reported the following day that they had experienced a ¿warm feeling on the implant area¿ and ¿ineffective therapy despite the stimulus being effectively delivered. ¿ the patient¿s hcp evaluated the implant location for signs of inflammation or lesion but found nothing to report. Impedance testing was performed and the system was evaluated to ensure proper recharging; however, there was nothing to report. It was noted that although the patient reported ¿short recharging between intervals,¿ it was found that this was consistent with the energy profile of the patient¿s therapy. The hcp ultimately decided to perform a revision surgery in order to inspect the implant region and replace the ins; the ins was replaced and the issue was resolved. It was noted that although the patient had reported falling some weeks before the event, the hcp ¿didn¿t report any trauma signs from the event. ¿ this may have led or contributed to the issue. There were no further complications reported or anticipated. The patient was alive with no injury at the time of report.
 
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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 Key12434442
MDR Text Key270155360
Report Number3004209178-2021-13428
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2018
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/28/2017
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: 09/07/2021 Patient Sequence Number: 1
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