BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4133321 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18067
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399945, LOT# V017264, IMPLANTED: 2007 (B)(6), EXPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377645, LOT# V015049, IMPLANTED: 2007 (B)(6), EXPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING THEIR BATTERY REPLACED THE DAY AFTER THE REPORT DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE BATTERY HAD BEEN DEAD FOR TWO TO THREE YEARS. THE PATIENT STATED THAT WHEN SHE HAD AN IMPLANT DONE IN (B)(6) 2008 SHE WENT THROUGH ¿HELL.¿ THE PATIENT REPORTED SHE WAS ON THE FLOOR ALL DAY AND EVERYONE ELSE WAS GOING IN FOR THEIR SURGERIES BUT THEY NEVER GOT TO HER. THE PROCEDURE WAS DONE LATE AT NIGHT AND THE DOCTOR DID A RUSH JOB. THE PATIENT REPORTED THAT THERE WAS NO ANESTHESIOLOGIST THERE AND SHE WAS SCREAMING AT THE TOP OF HER LUNGS. THERE WAS NO ONE THERE TO PROGRAM THE DEVICE AND WHEN THEY TOOK IT OUT THEY PULLED IT OUT WITH A TORQUE. WHEN THE PATIENT WENT BACK TO HAVE THEM ¿HOOK IT UP,¿ THEY COULDN¿T GET THE DEVICE PROGRAMMED. THE PATIENT WAS TOLD SHE WOULD HAVE TO HAVE ANOTHER SURGERY, AND HAD THE WHOLE THING REDONE BY A DIFFERENT SURGEON IN (B)(6) 2011. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610761 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention