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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); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

(b)(6). Information was received from a patient regarding their neurostimulator (ins) that was implanted for non-malignant pain and failed back surgery syndrome. Caller reported poor communication. Patient thinks her implant battery is dead because it won't charge. Patient had been having an issue where the implant battery would only charge a half then would only charge a quarter and then it wouldn't charge at all and she finally gave up and implant battery died. This occurred about 2-3 months ago; an exact date was not provided. The last time patient was able to successfully charge was over a month, probably 2-3 months ago. During the call, when patient tried to charge ins she was seeing the reposition antenna screen. Patient was unable to communicate with the external devices and unable to connect with the patient programmer. Patient was redirected to their hcp to address possible overdischarge. Later, patient called back and stated that they called the doctor's office and they said they would be inviting a rep to her upcoming appointment. No symptoms were reported and 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. The patient reported that her stimulator (ins) was no longer working as it should. The patient reported that she had an appointment set up. The patient reported that it was pretty much determined that the battery was at end of life, as it was implanted when it was new. The battery had died and needed to be changed. No further complications were reported.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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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 Key7658021
MDR Text Key113004475
Report Number3004209178-2018-14858
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
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 10/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2013
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 Received08/08/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/13/2012
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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