BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1231227 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07407
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 13, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE LYING DOWN THE PATIENT EXPERIENCED SHOCKING FROM THE NIPPLE LINE ON HIS CHEST DOWN TO HIS TOES. THE DEVICE WAS OFF AT THE TIME. THE PATIENT CONTINUED TO EXPERIENCE CONSTANT SHOCKING AND EACH TIME NOTED THE DEVICE WAS OFF. TWO DAYS AFTER THE INITIAL EPISODE, THE PATIENT EXPERIENCED SHOCKING THAT LASTED 10 MINUTES. THE DEVICE WAS AGAIN VERIFIED TO BE OFF. ADDITIONAL INFORMATION REPORTED THAT PALPATION DID NOT REPRODUCE THE SENSATION. IMPEDANCE READINGS SHOWED ALL IMPEDANCES >3600 OHMS AT 0.24V. THERAPY IMPEDANCES WERE WITHIN NORMAL LIMITS (758 AND 600 RESPECTIVELY ON PROGRAMS 1 AND 2). IT WAS ALSO REPORTED THAT THE PATIENT WAS GETTING GOOD THERAPY WHEN NOT GETTING SHOCKING. THE PATIENT WAS GOING TO KEEP A DIARY OF WHEN THE SYMPTOMS OCCURRED, VERIFY WITH EACH EPISODE THAT THE DEVICE WAS OFF, AND NOTE WHAT THE LAST PROGRAM WAS THAT WAS USED. NO PATIENT 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 RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083| EXTENSION: MODEL 37083| RECHARGER: MODEL 37752| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3999| PROGRAMMER: MODEL 37742