BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2954833 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02490
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 22, 2013
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID: 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE INS STOPPED WORKING TWO MONTHS AFTER IMPLANT. THE PATIENT TRIED TO TROUBLESHOOT WITHTHE HCP, BUT THE HCP WAS REPLACING THE BATTERY AS THEY COULD NOT FIX THE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD STIMULATION IN THE WRONG LOCATION AND WASN'T FEELING STIMULATION IN THEIR LEGS. INCREASED PAIN WAS ALSO REPORTED. NO KNOWN ACCIDENT OR INCIDENT WAS REPORTED IN RELATION TO THIS. RECHARGING PROBLEMS WERE ALSO NOTED SINCE (B)(6) 2012. AS OF THE DATE OF THIS REPORT, IT WAS REPORTED, THE DEVICE WAS OFF AND WAS "NOT WORKING." IT WAS STATED, THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT LYING FLAT. THE INS WAS "AT AN ANGLE" AND WAS PAINFUL FOR THE PATIENT. A FLIP OF THE INS WAS NOT CONFIRMED. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW UP RECEIVED REPORTED THAT THE PATIENT WAS UNABLE TO GET MORE THAN 2 COUPLING BARS BETWEEN THE RECHARGER AND THE INS AND WOULD QUICKLY LOSE THAT CONNECTION. THE PATIENT GAVE UP RECHARGING THE INS SEVERAL MONTHS AGO AND IT WENT INTO AN OVERDISCHARGE CONDITION. PALPATION OF THE INS SITE NOTED THAT IT WAS DEEP AND WAS NOT OBVIOUS LEVEL. THE PHYSICIAN THEN REVISED THE POCKET SITE ON (B)(6) 2013 SO THAT THE DEVICE WAS NOW LESS THAN 1 CM BELOW THE SURFACE OF THE SKIN AND LEVEL. SINCE IT WAS BELIEVED THAT THERE WAS "SOME DEGREE OF BATTERY DAMAGE", THE INS WAS ALSO REPLACED DURING THE REVISION SURGERY. THE PHYSICIAN BELIEVED THAT THE INS WAS DEFECTIVE AND THEREFORE WAS UNABLE TO CHARGE NORMALLY. THE EXPLANTED INS WAS CURRENTLY IN THE POSSESSION OF THE HOSPITAL'S PATHOLOGY DEPARTMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT LATER REPORTED ON (B)(6) 2014 THAT WHEN SHE WOULD CALL INTO THE DEVICE MANUFACTURER IT NEVER WORKED TRYING TO TROUBLESHOOT. THE PATIENT'S HCP TRIED EVERYTHING BUT THE DEVICE GAVE OUT, WOULD NOT TURN ON. IT WAS NOTED THAT THE PATIENT HAD 3 DIFFERENT SURGERIES FOR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58836 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 00034 YR Required Intervention