BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3315770 · Received August 29, 2013

    Report

    Report Number
    3004209178-2013-15373
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Report Date
    August 5, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 377860, LOT# V013676, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V002517, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NOT USED STIMULATION FOR OVER TWO YEARS OR CHARGED FOR YEARS BECAUSE THEIR NEUROPATHY PAIN HAD BEEN FINE. ABOUT TWO WEEKS PRIOR TO REPORT, THE PATIENT HAD FELT STIMULATION A ¿FEW TIMES¿ LIKE IT WAS ¿TURNING ITSELF ON.¿ IT WAS NOT PAINFUL BUT IT SURPRISED THE PATIENT. THE PATIENT DID NOT REMEMBER IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED TO 0V AND OFF OR JUST TURNED OFF. THE PATIENT HAD NOT FOLLOWED UP WITH THE HEALTHCARE PROFESSIONAL (HCP) BUT WAS REDIRECTED TO THE HCP. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427933 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR