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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 97713
Device Problems Migration or Expulsion of Device (1395); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Weight Changes (2607)
Event Date 07/10/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: date is approximate. Occupation: non-healthcare professional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain. It was reported that there was poor coupling. The patient said they can't get their device to work, they were trying to charge the ins but they were not getting any coupling boxes. The patient attempted an antenna locate (al) on the call but was only able to get a 6 as the highest number. The patient confirmed they were confident they had the antenna directly over the ins. The patient stated that the ins site had been hurting a little and there was pain at the ins site because it had moved and had been sitting closer to the skin. Patient services (ps) reviewed the possibility that the ins could be flipped or in a position that was causing the poor coupling. The patient later called and repeated that they were having coupling issues during recharge. Ps had the patient try the al feature and they stated they saw "8" for the al connection. Ps tried to have the patient reconnect and charge but the recharger screen seemed to freeze up. The patient called again stating they were having trouble with the bars on the recharger and it was showing it was charging. Ps worked with the patient to do a manual reset of the recharger and it was successful to clear the frozen screen. The patient reported 6 black coupling boxes but lost them quickly but was able to get them back by repositioning the antenna; adhesive discs were ordered for the patient. The patient was directed to their healthcare professional (hcp) to check the ins. The patient said they called their hcp and the hcp told them to call a manufacturer representative to check the ins, so an email was sent to the local field staff. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient. It was reported that the patient gained weight and the ins moved closer to the skin. The patient massaged the area of the stimulator. The patient said coupling issues, the device not working, the stimulator moving closer to the skin and the pain at the stimulator site has been resolved. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7719975
MDR Text Key115413143
Report Number3004209178-2018-16644
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,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2016
Device Model Number97713
Device Catalogue Number97713
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/09/2015
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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