BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1080197 · Received July 22, 2008

    Report

    Report Number
    3004209178-2008-04238
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 27, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    YES.

    Description of Event or Problem · 1

    THE PT WAS AT WORK MOVING A HOSPITAL BED. THE PT WAS PINNED BY THE BED AGAINST THE WALL. DURING THAT TIME, SHE EXPERIENCED AN EXTREME SHOCKING SENSATION. AFTER THE PT WAS FREED FROM BEING PINNED, THE SHOCKING SENSATION WENT AWAY. THE PT REPORTED THAT SHE HAD NOT EXPERIENCED SHOCKING SINCE THE INCIDENT. THE PT WAS AT HOME. THE PT WAS ENCOURAGED TO CONTACT HER HCP. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESSORY MODEL 37752 LOT# NKA029212N| LEAD MODEL 3778-60 LOT# V035242008| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER MODEL 37742 SERIAL #UNK| EXPLANTED:| LEAD MODEL 3778-60 LOT# V035242007