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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 Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)
Patient Problems Irritation (1941); Device Overstimulation of Tissue (1991); Discomfort (2330); Malaise (2359); Electric Shock (2554)
Event Date 04/01/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The consumer reported that he started feeling an electrical shock in the extremities of his body and overnight it started traveling up and down his body. The patient stated that after 1-2 hours his wife stated he jumped off the bed. The patient noted there were two electric charges going up and down his body and he didn¿t think anything of it. The patient charged the implant the day before the call and after he was done charging stimulation got really strong. The patient turned the implant off and put it in mri mode and with it being off he still had charges traveling but they were slower and popping up at random places. The patient mentioned it was irritating and for the past month or so he had been experiencing discomfort in the area where the implant was and at another spot about six inches underneath. When asked about weight changes it was reported the patient gained and lost weight all the time and it was not uncommon for him to gain or lose 25. The patient stated he had an ultrasound of his bladder two weeks ago and the healthcare provider followed the guidelines and there were no other traumas, falls or medical tests that could be related to the issue. The patient mentioned he was currently sick. The change in therapy or symptoms was considered sudden. The indication for use was 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6586001
MDR Text Key101649104
Report Number3004209178-2017-10891
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 05/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
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 Received05/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/30/2016
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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