BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1650618 · Received April 1, 2010

    Report

    Report Number
    3004209178-2010-02612
    Event Type
    Injury
    Date Received
    April 1, 2010
    Date of Event
    February 1, 2007
    Report Date
    March 1, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2007, THE PATIENT EXPERIENCED A RASH WITH WARMTH, REDNESS, DISCOLORATION OF THE SKIN, ITCHING AT AND AROUND THE SITE OF THE IMPLANT - RIGHT ABDOMEN THAT APPEARED TO BE POSSIBLE INFECTED. AN ALLERGY TEST WAS NEGATIVE. BIOPSY RESULTS OF RASH DIAGNOSED ERYTHEMA AB IGNE. THE HCP INDICATED THE DEVICE WAS NOT INFECTED. PICTURES OF THE RASH APPEARED AS RED AND BROKEN BLOOD VESSELS. THE HCP INDICATED THE PATIENT HAD A HISTORY OF "HEAT" AT THE DEVICE SITE. THE PATIENT ALSO COMPLAINED THAT THE STIMULATION WOULD WORK FOR A WHILE AND THEN FADE AWAY. THE STIMULATION WAS NOT CONSISTENT. IMPEDANCE READINGS WERE WITHIN NORMAL LIMITS. THE DEVICE AND BOTH EXTENSIONS WERE REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO. 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention EXTENSION: MODEL 7489, LOT #NHU107577V| EXTENSION: MODEL 7489, LOT #NHU115408V| PROGRAMMER: MODEL 7435, LOT #NFT059553P| LEAD: MODEL 3998, LOT #V008174