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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211)
Patient Problems Irritation (1941); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Malaise (2359)
Event Date 09/08/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The consumer reported a loss of stimulation and a return of symptoms. It was reported that their stimulator was for their left upper arm and was in the thoracic area but they were not feeling the stimulation sensation but also had a return of pain. There was a report that the patient was very sick in bed with a cold for a couple of weeks and was coughing really bad. They reported that their coughing activated their sciatica. A ct scan was reported to be performed for a brain aneurysm and the spinal cord stimulator was working fine until that night after having the ct scan. The patient increased the amplitude from 0. 85 to 0. 90 but it was reported that the programmer showed that the stimulation was off. Turning on stimulation did not resolve the reported issue. They were still not feeling stimulation sensation after turning therapy back on. The patient increased amplitude from 0. 90 to 2. 7 and now could feel the stimulation sensation again, however the patient had not noticed any immediate pain relief. It was reported that the patient would contact their healthcare professional (hcp). Relevant medical history includes spinal pain.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key5993195
MDR Text Key102534085
Report Number3004209178-2016-20206
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2016
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/08/2015
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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