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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 Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Nerve Damage (1979); Pain (1994); Injury (2348)
Event Date 04/12/2017
Event Type  Injury  
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
Information was received from a patient with an implantable neurostimulator (ins) for the treatment of spinal pain via a manufacturer representative. It was reported that the patient was having difficulty with pain. It was reported that the patient had a physician mode reset (pmr) on (b)(6) 2017. The patient reported that they had a hard time getting the ¿sweet spot¿ for recharging and noted that they had been charging for 12 hours every two weeks. The antenna locate software was also used at the appointment on (b)(6) 2017. The patient reported that they were always able to feel the stimulation, but that it was causing more pain than it was helping. The patient reported that they had an extensive traumatic injury in their left lower leg and they had felt a radiating pain from their sciatic nerve down their left leg since implant. The patient mentioned that they had nerve damage in their left leg. No further complications are anticipated.
 
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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 Key6666686
MDR Text Key102504362
Report Number3004209178-2017-13680
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2018
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 Received06/02/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/14/2017
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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