• 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 RESTORE SENSOR 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 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37714
Device Problems High impedance (1291); Overheating of Device (1437); Unable to Obtain Readings (1516)
Patient Problems Burning Sensation (2146); Discomfort (2330)
Event Date 06/01/2018
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 manufacturer representative regarding a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain and failed back surgery syndrome. It was reported that the patient was having burning and stinging in the pocket area when the therapy is turned on. The patient noted that this happens at night and when they are recharging. The manufacturer representative checked the impedances and 5 contacts on the left lead had impedances of > 20k ohms and on the right lead, 2 contacts had impedances of > 20k ohms (depending on the reference electrodes). The manufacturer representative attempted to program around the specific electrodes and it did not resolve the issue. The patient was receiving therapy in their legs. No further complications are anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative (rep) on (b)(6) 2018. It was reported that the cause of the burning/stinging at the ins site and the high impedances was unknown at the time of the report. To resolve the issue, the rep tried to reprogram around the electrodes, but it didn¿t help. Lastly, it was reported that a surgery was planned to resolve the reported symptoms and device issues, but a date was not yet set. There were no further complications reported or anticipated.
 
Manufacturer Narrative
Continuation of d11: product id 3778-60 lot# serial# (b)(4) implanted: explanted: product type lead product id 3778-60 lot# serial# (b)(4) implanted: explanted: product type lead section h reflects the main component and other applicable components. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from rep. It was reported that a revision took place today.
 
Manufacturer Narrative
Additional review indicated the information in mfg report 238156930 is related to this event. Any additional information regarding the event will be sent as a supplemental submission to this report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The rep ran impedances and results showed some values were >10000 ohms and some were "xxx". Rep stated not all values were 10000ohms. The rep stated that he thought that the md was going to replace the leads with a paddle and may replace the ins so he was not concerned about the high values. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep. It was reported that the cause was not determined and everything looked normal when pocket was opened and explant occurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7658731
MDR Text Key113027560
Report Number3004209178-2018-14888
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was 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
Device Expiration Date02/28/2013
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 Received10/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/04/2012
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: 07/03/2018 Patient Sequence Number: 1
-
-