BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1153089 · Received September 8, 2008

    Report

    Report Number
    3004209178-2008-05526
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTENSION WAS RETURNED TO THE MFR FOR ANALYSIS ON 8/26/2008 WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE IMPLANTABLE NEUROSTIMULATOR WAS MOVED FROM THE BUTTOCK TO THE ABDOMEN (REASON NOT REPORTED). DURING SURGERY, THE HCP NOTED THAT THE EXTENSION WAS BROKEN AND SUBSEQUENTLY REPLACED. IMPEDANCES WERE WITHIN NORMAL LIMITS BEFORE AND AFTER SURGERY. THERE WAS NO PT SYMPTOMS SECONDARY TO THE BROKEN LEAD BEFORE OR AFTER SURGERY. THE PT OUTCOME WAS REPORTED AS 'NO INJURY, RECOVERED WITHOUT SEQUELAE'. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L 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 LEAD MODEL 3778 LOT# V023008020| RECHARGER MODEL 37752 LOT# NKA026829N| IMPLANTED| LEAD MODEL 3778 LOT# V007756| EXTENSION MODEL 37081 LOT# NJB007666V| IMPLANTED| PROGRAMER MODEL 37742| EXPLANTED| IMPLANTED| EXPLANTED| EXPLANTED