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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 97713
Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
Patient Problem Electric Shock (2554)
Event Date 08/07/2021
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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. Rep called with patient who is reporting that they are getting no communication to the ins using the patient programmer, insr and tablet. Pt states two days ago after placing a heating pad over the ins, pt felt a "shock" at his device and therapy stopped. Pt reports that he last charged ins last wednesday and had no issues charging or using his device. Ts recommended to reset the ins today, attempted a short prm which did not result in por. Insr was still showing "reposition the insr antenna" screen. Ts suggested to do a prm for full 60 min and try again and continue doing a prms until ins starts responding. Once por message is seen and battery charged to 25% then interrogate the ins check system. Ts reviewed that we don't anticipate that a heating pad would cause any issues with the ins. Rep also reviewed that the other device (37713-for cervical) was replaced today due to eos-normal battery replacement. No issues or concerns with that device.

 
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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 Key12313817
MDR Text Key266239182
Report Number3004209178-2021-12320
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2018
Device MODEL Number97713
Device Catalogue Number97713
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/30/2017
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: 08/12/2021 Patient Sequence Number: 1
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