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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); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative

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 failed back surgery syndrome and non-malignant pain. There was poor communication. The patient reported that they cannot charge their implant and lost connection from the ins to their recharger. They have not used their implant in a long time. Therefore, they have not charged it for over a year. The patient¿s reason for not charging was because they have been a ¿bad boy¿ and did not charge their implant. The patient was redirected to follow up with their healthcare professional (hcp). Additional information was received from the manufacturer representative on 2018-may-22. It was reported the patient states the battery needs a trickle charge. The battery has been off and has not charged in over a year. The patient did not bring his equipment to the appointment with representative. The representative tried to read the ins with the clinician programmer and was unable to read as battery was overdischarged. The patient was advised to make an appointment and bring all his charging equipment. Will attempt to trickle charge. Since this was the second time the battery was overdischarged (per patient) the patient was advised they may not be able to get it started and would need to have it replaced. The issue was not resolved at the time of the reported. Additional information was received from a manufacturer representative regarding the patient on 2018-jun-29. It was reported that the device was overdischarged and was planned to be replaced, but the replacement surgery was not yet scheduled. There were no further complications reported or anticipated.

 
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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 Key7655924
MDR Text Key112933810
Report Number3004209178-2018-14808
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 07/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/14/2013
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 Received06/29/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/17/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/02/2018 Patient Sequence Number: 1
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