BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2030444 · Received March 9, 2011

    Report

    Report Number
    3004209178-2011-01801
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MDT 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

    THE PT WAS TRIALING AN OCTAPOLAR LEAD. SHE HAD AN EXISTING RECHARGEABLE SYSTEM IMPLANTED WHICH UTILIZED A SURGICAL LEAD. THE PLAN WAS TO UNPLUG THE EXTENSION FROM THE 8-15 PORT AND USE THAT PORT TO CONTINUE TRIALING THE OCTAPOLAR LEAD. UPON TESTING THE 8-15 PORT, IMPEDANCE OF GREATER THAN 10,000 OHMS WAS OBSERVED. THE OUTCOME IS UNK. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB038737V| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE128342N| ACCESSORY: MODEL 37752, LOT# NKA128958N| LEAD: MODEL 39565-30, LOT# V297513001| EXTENSION: MODEL 37081, LOT# NJB053579V| EXPLANTED: