BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3090123 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07218
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 24, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THAT IS FELT AS THOUGH THE DEVICE WAS ¿PROTRUDING FROM HER SKIN¿.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A COUPLING PROBLEM. PALPATING THE INS POCKET CONFIRMED THAT THE INS WAS NOT FLIPPED. SHE WAS NOT ABLE TO OBTAIN EFFICIENCY BARS ON THE CHARGER AND BUT WAS ABLE TO CONNECT TO IT. THE SCREEN THEN CHANGED TO 'CALL YOU DOCTOR' ICON WHICH WAS INTERMITTENT. NO CODE DISPLAYED. IT WAS NOTED THAT SHE HAS HAD TO REPOSITION THE ANTENNA OVER HER SKIN, OVER 15 TIMES. WHEN SHE TRIED TO ADJUST THE ANTENNA IT CAUSED HER SHOULDER PAIN. ADJUSTING THE ANTENNA DIAL ON THE RECHARGER DID NOT HELP. LAST NIGHT SHE FELT A TRICKLING SENSATION OR PINS AND NEEDLES PAIN ON HER BACK AND THEN FELT A ZAPPING SENSATION. IT FELT LIKE SHE STUCK HER FINGER IN AN ELECTRIC SOCKET. SHE ALSO FELT THE SHOCKING IN THE MORNING AS WELL. THE NEXT DAY IT WAS REPORTED THAT THE SHOCKS HAVE OCCURRED 3 TIMES IN THE LAST COUPLE DAYS. ONE OCCURRED WHILE SHE WAS SITTING IN A RESTAURANT ON (B)(6) 2013. ANOTHER OCCURRED WHILE SITTING ON THE COUCH WHICH WAS NOT RELATED TO CHANGING POSITIONS. SHE FELT PARESTHESIA SIMILAR TO 'WATER DRIPPING DOWN MY BACK' AND THEN THE SHOCK OCCURRED. THE INS WAS ON FOR ONE OF THE SHOCKING EPISODES BUT THEN WAS OFF FOR THE OTHER EPISODES. HER INS WAS CURRENTLY OFF. SHE HAD LOST THE ANTENNA FOR HER PATIENT PROGRAMMER AND DID NOT KNOW SHE COULD USE IT WITHOUT THE ANTENNA. IT WAS NOTED THAT SHE WAS HAVING ISSUES WITH HER INSURANCE SO ONCE SHE DEALS WITH THAT SHE WAS GOING TO MAKE AN APPOINTMENT WITH HER HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER HAS NOT SEEN THE PATIENT SINCE (B)(4) 2012. AT THAT TIME SHE HAD NO PROBLEMS AND THE DEVICE WAS WORKING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192164 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 00033 YR