BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1091507 · Received August 1, 2008

    Report

    Report Number
    3004209178-2008-04584
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 2, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED ALL THE CONDUCTORS/WIRES WERE BROKEN IN THE BODY OF THE LEAD 23.5 CM FROM THE DISTAL END AT THE TITAN ANCHOR SITE. THE SILICONE PORTION OF THE ANCHOR WAS SEPARATED FROM THE TITANIUM INSERT.

    Description of Event or Problem · 1

    THE PATIENT DIDN'T FEEL PARESTHESIA. WHEN DOING A DEVICE SYSTEM CHECK, ALL IMPEDANCES WERE GREATER THAN 4000 OHMS. DURING REVISION SURGERY, IMPEDANCES WERE AGAIN GREATER THAN 4000 OHMS WHEN RECHECKED WITH THE SNAP LID CABLE. THE LEADS WERE REPLACED AND ALL IMPEDANCES WERE NORMAL. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY, RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| LEAD (X2) MODEL 347745| TITAN ANCHOR LOT# UNK| IMPLANTED| EXTENSION MODEL 37081| IMPLANTED| EXPLANTED| EXTENSION MODEL 37081| EXPLANTED| PROGRAMMER MODEL 37742