BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1902191 · Received November 15, 2010

    Report

    Report Number
    3004209178-2010-09551
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 9, 2010
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT ABLE TO ADJUST STIMULATION. THE STATUS LIGHTS WERE ASSESSED. THE SWITCH POSITION WAS ASSESSED. THE PROGRAMMER DIDN'T PASS THE SELF-TEST. THE PT ALSO NOTED NO STIMULATION SENSATION. THE PROGRAMMER WAS REPLACED. THE REPLACED STIMULATOR ALSO DID NOT RESPOND TO THIS PROGRAMMER. IT WAS NOTED THAT THE STIMULATOR MAY HAVE BEEN AT END OF LIFE (EOL). THE PT UNDERWENT SURGERY ON (B)(4) 2010. THE STIMULATOR WAS REPLACED. THE PT WAS STILL HAVING PROBLEMS WITH THE SYSTEM FOLLOWING STIMULATOR REPLACEMENT. ADDITIONAL 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 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention PROGRAMMER: MODEL 7435, LOT# NFT053719P| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT062883P| LEAD: MODEL 3998, LOT# J0546367V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU102307V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU102311V