BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2935540 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01121
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 12, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-39, LOT# N320417, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DESK TOP CHARGER TOOK 'A LONG TIME' TO RECHARGE. THE PATIENT HAD TO RECHARGE THEIR BATTERY FOR 'MORE THAN 5 HOURS TO GET TO 50%. IT WAS NOTED THAT THE RECHARGER 'GOT HOT ON THE PATIENT'S SKIN.' IT WAS STATED THAT THE PATIENT SAW A DOCTOR AND COMPANY REPRESENTATIVE AND THEY THOUGHT IT MIGHT BE THE RECHARGER. IT WAS LATER REPORTED THAT THE PATIENT WAS UNABLE TO MAKE ADJUSTMENTS WITH OR WITHOUT THE ANTENNA ATTACHED. THE PATIENT FELT A WARM SENSATION IN OR AROUND THE BATTERY POCKET DURING RECHARGING. THE PATIENT WAS ALSO GETTING A 'RED BURN MARK' WHERE SHE CHARGES. IT WAS NOTED THAT THE PATIENT DOES HAVE A SPACER. IT WAS STATED THAT THIS STARTED HAPPENING 'MONTHS AGO.' NO SPECIFIC DATE WAS REPORTED. NO FURTHER INFORMATION WAS RECEIVED. IF MORE INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40880 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