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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427
Device Problems Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516); Battery Problem (2885); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)
Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)
Event Date 10/18/2019
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 regarding a patient with an implantable neurostimulator (ins) for arachnoiditis. It was reported that the patient was advised to contact the manufacturer to schedule a rep to come to the hcp office to check the patient's ins. The caller said the patient's ins hasn't worked since he had his heart shocked out of a-fib. The caller said it was working prior to the procedure. The caller said the patient's back started to really bother them the night prior to the report. The patient could not feel stim, so they tried increasing it with the programmer but the efforts were unsuccessful. The caller said they saw 2 green lights and 1 yellow on the programmer. It was reviewed the ins was off. The patient turned on the ins and confirmed that all 3 green lights were lit. The patient tried to increase stimulation and hears 3 audible beeps, indicating that he likely reached the maximum range set by the hcp. The patient said he still could not feel stimulation. No further complications were reported.

 
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Brand NameSYNERGY
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 Key9250183
MDR Text Key177243324
Report Number3004209178-2019-20613
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,Followup
Report Date 11/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2005
Device MODEL Number7427
Device Catalogue Number7427
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 Received10/30/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/12/2004
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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