BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3821903 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09310
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT DID NOT ACTUALLY LOSS STIMULATION FOR A FEW DAYS; THEY JUST NEEDED TO TURN THE AMPLITUDE HIGHER THAN USUAL. AN IMPEDANCE TESTING ON THE IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED ALL WERE NORMAL. IT WAS NOTED THAT THE PATIENT DID NOT SEE ANY ERROR CODE ON THEIR PROGRAMMER OR RECHARGER. NO FURTHER ACTIONS WERE TO BE TAKEN. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. LESS THAN 50% THERAPY RELIEF. THE PATIENT WAS WORKING ON HIS STOVE AT HOME AND GOT ELECTROCUTED, HE WAS FINE BUT LOST STIMULATION FOR 3 DAYS. THE PATIENT HAS SINCE REGAINED THE ABILITY TO USE HIS SPINAL CORD STIMULATION (SCS) BUT HAS TURNED IT UP HIGHER THAN HE HAD IT BEFORE THE INCIDENT. THE PATIENT WILL BE SEEN ON (B)(6) 2014. IT WAS FURTHER REPORTED THAT WHEN THE PATIENT WAS WORKING ON HIS STOVE, HE THOUGHT IT WAS UNPLUGGED. THE PATIENT ELECTROCUTED HIMSELF TO THE TUNE OF FEELING A SHOCK THROUGH HIS HAND AND ARM THEN EXITED OUT THE OPPOSITE SIDE OF HIS BODY. THE PATIENT WAS KNOCKED OUT FOR A FEW MINUTES AND COULD NOT SPEAK FOR A BIT BUT SEEMS PERFECTLY FINE NOW. THE PATIENT WAS UNABLE TO TURN THE SCS ON FOR 3 DAYS AFTER THE INCIDENT BUT IT WORKS FINE NOW EXCEPT HAVING TO TURN IT UP TO 3.2 TO 3.5 NOW WHICH IS HIGHER THAN HIS USUAL 2.1. NO ERROR CODE WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300072 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1