BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2980822 · Received February 27, 2013

    Report

    Report Number
    6000032-2013-00047
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# LB5800, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONALE INFORMATION REPORTED THE PATIENT'S DEVICE "FAILED" AND THE LEADS WERE LEFT IN INTNETIONALLY. IT WAS NOTED THE STIMULATOR WAS REMOVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE LEADS BROKE FREE AND "SENT THE UNIT AT THE BOTTOM." IT WAS NOTED THE SURGEON SAID IT WAS IMPOSSIBLE TO TAKE THE LEADS OUT, "IT WAS ALREADY AFFIXED TO THE BODY." IT WAS STATED THAT REMOVING THE LEADS WOULD HAVE BEEN "MORE TROUBLE" THAN NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S "LEADS FAILED." IT WAS STATED THAT THE PAIN STIMULATION DEVICE WAS REMOVED, BUT THE LEADS WERE LEFT IMPLANTED. THE PAIN STIMULATION DEVICE REPORTEDLY "WORKED GREAT", HOWEVER, WHEN HE "ATTEMPTED TO INCREASE IT, IT MOVED TO RIGHT MIDDLE OF BACK." IT WAS STATED THAT THE UNIT WAS "ON THE PELVIS AND BROKE FREE," AND THAT THE "OLD LEADS WERE OFF TO THE RIGHT AND ABOVE RIGHT KIDNEY". IT WAS NOTED THAT THE HEALTH CARE PROVIDER TOLD THE PATIENT THAT 'IT WAS HIS FAULT," AND "ACCUSED HIM OF DOING SOMETHING WRONG." NO FURTHER INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THE PATIENT¿S SPINAL CORD STIMULATION SYSTEM WAS REMOVED IN 2004. IT WAS REPORTED THE HEALTH CARE PROVIDER DID NOT TAKE THE LEADS OUT BECAUSE OF ¿SUBDURAL FAT ADHESION.¿ IT WAS REPORTED THE LEADS WERE EVENTUALLY REMOVED FROM THE PATIENT, BUT IT WAS NOT CLEAR WHEN. ADDITIONAL INFORMATION REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY AND RECEIVED ASSISTANCE FROM THEIR HEALTH CARE PROVIDER ON (B)(6). IT WAS UNCLEAR WHICH DEVICE THIS INFORMATION RELATED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85680 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention