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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); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009)
Patient Problems Pain (1994); Malaise (2359)
Event Date 10/10/2016
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 patient who was implanted with a neurostimulator for failed back surgery syndrome and spinal pain. It was reported that there was no telemetry with recharging. The patient turned therapy off after he realized that he was not able to charge the implantable neurostimulator. The patient last successfully recharged the device the third week of (b)(6) 2016. The patient normally has to charge every 2 weeks. After repositioning the antenna, he was not able to communicate with the patient programmer or the implantable neurostimulator recharger. The patient was getting the poor communication message while attempting to sync with the patient programmer. The patient was sick and had gone from (b)(6) pounds in 6 weeks and the outline of the generator was very easily seen under his skin. Where the wires go into the generator have been stabbing him and the corner of it has been stabbing him also. The patient did not think that the implantable neurostimulator had flipped because the wires were still in the same place because he can feel the indentation of where the wires would go. The problems with the implantable neurostimulator site and the wires stabbing the patient started to occur in (b)(6) 2016. The issues with not being able to charge the implantable neurostimulator started around the second week in (b)(6).
 
Event Description
Additional information was received from the patient on 2016-12-01 reporting that the patient had just called their health care professional (hcp). The hcp had asked the consumer to get in contact with a manufacturer representative. The process of requesting a meeting with a manufacturer representative was reviewed. Patient services information a manufacturer representative regarding the upcoming request that would be coming from the hcp.
 
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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
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263987
MDR Report Key6129079
MDR Text Key103270879
Report Number3004209178-2016-24725
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2014
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 Received12/01/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/17/2013
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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