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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2018
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 consumer via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain. It was reported there was an alleged overdischarge. The rep stated the patient told them the ins battery depleted 2 weeks ago, but now the patient couldn¿t recharge, and the patient programmer couldn¿t connect with the implant. The rep also mentioned the patient recharged to full one day and the ins was depleted in one day. The patient tried again, and the same thing happened. The rep suspected it was the implantable neurostimulator recharger (insr) giving a bad reading. It was reviewed with the rep that insr generally don¿t give bad readings, that the patient might have a short circuit in the battery if it was depleting in one day, assuming there was no new programming or usage causing the battery depletion. It was recommended the rep do a physician mode reset to get the device working again. It was noted once the ins had the ability to be interrogated then the rep should do an impedance check for any short circuit, if none was found then an insr replacement would be recommended. There were no symptoms reported. It was noted the issue began in (b)(6) 2018. There were no further complications that have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep) reporting that it was determined that a physician mode reset was to be attempted. The cause if the ins being depleted, only lasting a day, the patient not being able to charge, the patient programmer not connecting, and the insr giving a bad reading was not determined. The rep said they were not made aware if the issues have been resolved. No further complications were reported.
 
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Brand NameRESTORE SENSOR
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key7580041
MDR Text Key110585590
Report Number3004209178-2018-12907
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 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2014
Device Model Number37714
Device Catalogue Number37714
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 Received06/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/29/2013
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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