BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4852520 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-11803
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Report Date
    May 28, 2015
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3887-33, LOT# J0222748V, IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 377875, LOT# J0555561V, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A MASSIVE BACK SURGERY THE YEAR PRIOR TO THE REPORT AND WAS FUSED FROM THE SACRUM TO T5. THE PATIENT STATED THIS HAD NOTHING TO DO WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) OR PUMP. ON (B)(6) 2014 THE PHYSICIAN ¿CUT THE WIRE¿ AND DISCONNECTED THE INS. THE INS AND LEADS WERE LEFT IN. ON (B)(6) 2014 THE PATIENT HAD A CENTRAL VENOUS STROKE; SHE TOOK A NAP AND WOKE UP AND COULDN¿T MOVE HER LEFT ARM AND HAD SLURRED SPEECH. IN (B)(6) OF 2014 SHE STARTED TO COMPLAIN OF PAIN. THEY WANTED TO PERFORM A CT MYELOGRAM TO SEE WHAT NERVES WERE ¿SCREWED UP.¿ BUT COULDN¿T TELL BECAUSE THEY COULDN¿T GET THE NEEDLE IN DUE TO THE PATIENT¿S 28 SCREWS AND TWO RODS IN THEIR BACK (THE PATIENT HAD A ROD THAT WAS BROKEN IN HER BACK). THE PHYSICIAN TOLD THE PATIENT THEY COULD TAKE THE MEDICATION OUT OF THE PUMP, SHE COULD GO TO THE PLACE WHERE THEY DO THE CT AND INJECT THE CONTRAST INTO THE PUMP, AND THEN THE PATIENT COULD GO BACK TO THE PHYSICIAN AFTER THE SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396468 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1