BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2193293 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05384
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, IMMEDIATELY POST-OPERATIVELY, SOME IMPEDANCE READINGS WERE IN THE NORMAL RANGE, SOME WERE ELEVATED, AND A FEW WERE GREATER THAN 40,000 OHMS. IMPEDANCE READINGS WERE NOT CONDUCTED INTRA-OPERATIVELY, PER THE PHYSICIAN. THE PT FELT STIMULATION WHEN PROGRAMMING WAS PERFORMED WITH SOME COMBINATIONS, BUT ONLY AT HIGHER VOLTAGES. THE PT HAD A LOT OF SCAR TISSUE AND THE LEAD PLACEMENT WAS MORE "COMPLICATED." IT WAS LATER REPORTED THAT THE IMPEDANCE READINGS IMPROVED LATER ON THE DAY OF IMPLANTATION. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT #NKE162259N| LEAD: MODEL 39565, LOT#V610205039| RECHARGER: MODEL 37752, LOT#NKA146732N