BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2050058 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02472
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 4, 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

    RECEIVED INFO STATING SEVEN DAYS AFTER SURGERY WHEN THE DEVICE WAS FIRST TURNED ON, THE PT REPORTED NO STIMULATION. STIMULATION WAS FELT ONLY AT VERY HIGH AMPLITUDES. HIGH IMPEDANCES OF >20,000 WERE FOUND. PT REPORTED TO ACCIDENT OR INCIDENT RELATED TO THIS EVENT. X-RAYS OF THE INS, LEADS AND OR EXTENSIONS WERE RECOMMENDED BUT AS OF THIS REPORT HAD NOT BEEN DONE. THE PHYSICIAN ELECTED TO GIVE IT TIME AND REPROGRAM ON THE LEAD WITHOUT HIGH IMPEDANCES. ADD'L INFO RECEIVED STATED THE PT DID NOT HAVE ANY FALLS RELATED TO THIS EVENT AS WAS FIRST SUSPECTED. NO X-RAYS WERE DONE. THE PHYSICIAN DECIDED TO GIVE IT TIME AND PROGRAM ON THE LEAD WITHOUT THE HIGH IMPEDANCES. IF FURTHER INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V634632010| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V637765030