BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3973818 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13853
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 11, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3987, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID: 7496-66, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS FURTHER REPORTED THAT DURING THE LAST COUPLE OF DAYS PRIOR TO THE REPORT THE PATIENT SUDDENLY HAD NOT BEEN ABLE TO LIFT THEIR ARM OR ROLL IN BED WITHOUT FEELING PINCHING OR PULLING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450393 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR