BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3163526 · Received June 11, 2013

    Report

    Report Number
    6000032-2013-00151
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3487A, LOT# J0005709V, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID: 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7495LZ51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3587A, LOT# L78633, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE ¿LEAKED¿ IN 2002. IT WAS UNCLEAR WHAT ¿LEAKED.¿ IT WAS NOTED THAT THE PATIENT LATER HAD ANOTHER DEVICE IMPLANTED AND IT WAS ¿GREAT.¿ REFERENCE MFR. REPORT #6000032-2013-00150 FOR A PREVIOUS DEVICE OF THE PATIENT¿S WITH A SIMILAR ISSUE.

    Description of Event or Problem · 1

    IT WAS NOTED THE DOCTORS "SCREWED THAT UP" DURING THE REPLACEMENT PROCEDURE. IT WAS REPORTED THERE WAS AN EXCHANGE OF BLOOD BETWEEN THE SYSTEM AND IT WASN'T ELECTRICALLY INSULATED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264621 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR