BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2244003 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-06760
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    August 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE CONTACTS WERE NOT WORKING AND THE PATIENT REQUIRED A REVISION. THE HCP PERFORMED A X-RAY TO CONFIRM THIS MALFUNCTION. ADDITIONALLY, THE PATIENT WAS EXPERIENCING PAIN IN HER LEFT SHIN. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. THE PATIENT HAD INSURANCE APPROVAL TO PERFORM THE PROCEDURE BUT WAS TRYING TO FIND A HCP TO SCHEDULE THE WORK.

    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 NA Female EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED: | EXTENSION: MODEL 7489, LOT# NHU123043V| EXTENSION: MODEL 7489, LOT# NHU123044V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: | IMPLANTED: | IMPLANTED: | LEAD: MODEL 3487A, LOT# V056633| LEAD: MODEL 3487A, LOT# V062562| PROGRAMMER: MODEL 7435, LOT# NFT065207P| UNK BOOT SERIAL # UNK | UNK BOOT SERIAL# UNK | PROGRAMMER: MODEL 7435, LOT# NFT065207P| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V062562| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU123044V| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# V056633| EXTENSION: MODEL 7489, LOT# NHU123043V