BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1231224 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07406
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED. THE EXACT DATE FOR THE REVISION SURGERY HAD NOT YET BEEN SCHEDULED. THERE WAS NO KNOWN INCIDENT RELATED TO THE LEAD MIGRATION. NO PATIENT SYMPTOMS, TREATMENT, OR OUTCOME WAS REPORTED. 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
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION: MODEL 37083| EXPLANTED:| RECHARGER: MODEL 37752| EXPLANTED:| PROGRAMMER: MODEL 37742| IMPLANTED:| IMPLANTED:| LEAD: MODEL UNK