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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); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Muscle Weakness (1967); Pain (1994); Malaise (2359); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)
Event Type  Malfunction  
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). The reason for call was the patient lost 50 lbs and about a year and a half ago their ins started to move in their pocket. The patient would move the ins around in order to communicate the recharger to the ins. At that point they started to have localized pain in the battery pocket when they pushed on the ins. About 3 months ago their ins pocket started to be sore and if the top of their ins was touched when the touch was released the patient felt a shock at the battery site, the patient said the feeling was different than their typical stimulation. About 1 1/2 months ago they started to have pain radiating down their right leg (on the side of their body where the pocket is). The patient started to feel full body spasms, pain in their legs, sick, colon issues, they felt weak, and their arms and legs felt heavy. The patient turned their stimulation off and the symptoms went away and then about 1 1/2 days after turning their stimulation back on they would again feel these symptoms (the patient did this process a couple of times). They met with pain doctor and they performed x-rays and said they didn't see any lead migrations in either their cervical or lumbar region. The health care provider redirected the patient to a medtronic representative to have further diagnostics performed. The patient was redirected back to their healthcare provider to further address the issue.

 
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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 Key12055663
MDR Text Key266711419
Report Number3004209178-2021-09878
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 06/23/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/14/2017
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 Received06/22/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/25/2016
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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