BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1915550 · Received November 5, 2010

    Report

    Report Number
    3004209178-2010-08934
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    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

    IT WAS REPORTED THERE WAS A SHOCKING OR JOLTING SENSATION IN THE PARESTHESIA AREA THAT WAS INTERMITTENT. CALLER REPORTS READING <250 OHMS ON PAIR 0-3. ALL OTHER READINGS WERE 609-1093 WITH ???'S ON SOME READINGS. IMPEDANCES WERE DONE AT 4.0 V AND 450 PW. ADD'L INFO 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 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT#: J0123243V| EXTENSION: MODEL 7495LZ, LOT#: NHK005377V| EXTENSION: MODEL 7495LZ, LOT#: NHK004918V| LEAD: MODEL 3888, LOT#: J0123243V| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT#: NFT018215P| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: