BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1213301 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06911
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    January 12, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST THERAPEUTIC EFFECT FROM THEIR SPINAL CORD STIMULATOR. THE PATIENT FELT NO STIMULATION SENSATION. THE DEVICE QUIT WORKING IN EARLY 2008. THE PATIENT WAS SEEN IN THE CLINIC TWO DAYS LATER. THE DEVICE WAS INTERROGATED AND FOUND TO HAVE NO BATTERY CHARGE LEFT. THE DEVICE WAS USED 24HRS/DAY AT 5.3 - 5.4 VOLTS AT NIGHT AND 6.0 VOLTS DURING THE DAY. THE PATIENT FELT THE DEVICE DID NOT LAST AS LONG AS IT SHOULD HAVE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A RECHARGABLE STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 37081| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081