• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37702
Device Problems Failure to Deliver Energy (1211); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 11/01/2012
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient saw an elective replacement indicator (eri) message and stated that ¿it's only been four years" and that the therapy had been off almost the entire time because they had turned the stimulation off (then lost their programmer). The eri was able to be bypassed and the patient confirmed the stimulation was off. The patient stated that they had been unable to feel the stimulation since the ins was implanted, regardless of how high they turned the amplitude and rate were turned up. They adjusted both the settings up as high as they could go during the current report and confirmed they did not feel the stimulation. The patient noted they reached the rate upper limit screen at ¿130¿ and increased the amplitude over 10. 5 volts. The physician was aware of the issue as well as the manufacturer¿s representative. The patient did not have a managing physician and was provide was some listings. The patient was going to follow up with a hcp for the lack of stimulation issue. There were no further complications reported or anticipated.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRIMEADVANCED
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 Key7660030
MDR Text Key113395106
Report Number3004209178-2018-14961
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 PATIENT
Type of Report Initial
Report Date 07/03/2018
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? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/14/2014
Device MODEL Number37702
Device Catalogue Number37702
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 Received06/27/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/16/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-