BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3830315 · Received May 23, 2014

    Report

    Report Number
    3007566237-2014-01425
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    February 5, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT GOT OUT OF THE CAR AND ¿TWISTED/PULLED¿ THEIR BACK AND FELT ¿SHARP/QUICK PAIN.¿ IT WAS NOTED THAT THE INCISION HAD SPLIT ¿AT THE BOTTOM ABOUT AN INCH AT THE SMALL¿ OF HER BACK. THE EVENT REPORTEDLY OCCURRED ON (B)(6) 2014. THE FOLLOWING DAY, THE PATIENT WENT BACK TO THE SURGEON; THE PHYSICIAN ASSISTANT (PA) REPORTEDLY GAVE THE PATIENT STITCHES AND ANTIBIOTICS. ON (B)(6), THE PA REPORTEDLY REMOVED THE STITCHES AS THE SPLIT ¿LOOKED GREAT.¿ LATER, THE INCISION ¿SPLIT OPEN AGAIN AT THE SAME PLACE¿ AND THE PA GAVE HER STITCHES AGAIN. A ¿COUPLE OF DAYS LATER,¿ THE INCISION SPLIT OPENED UP ¿BELOW THE STITCHES, LIKE IN A NEW PLACE ABOUT HALF AN INCH LONG NOW.¿ IT WAS NOTED THAT IT ¿KEPT DRAINING.¿ THE PATIENT REPORTEDLY WAS SENT TO THE WOUND CARE SPECIALIST WHERE THE ¿PAST MONTH¿ OINTMENTS AND BANDAGES HAVE BEEN CHANGED EVERY OTHER DAY. ON (B)(6) 2014, THE WOUND CARE SPECIALIST STATED THE ¿OOZE¿ WAS GETTING ¿DISCOLORED¿ AND NOT RUNNING CLEAR. IT WAS NOTED THAT UPON FURTHER INSPECTION, THE SPECIALIST ¿COULD MAKE OUT SOME WIRES.¿ THE PATIENT WAS SENT BACK TO THE SURGEON ¿WITHIN HOURS.¿ THE SURGEON REPORTEDLY SAID ¿EVERYTHING WAS COMING OUT.¿ IT WAS NOTED THAT A ¿TOTAL OF FOUR DOCTORS¿ STATED THE NEUROSTIMULATOR WAS ¿COMING OUT.¿ THE PATIENT WAS ¿AT A LOSS FOR WORDS¿ AND WAS ¿NUMB,¿ STATING THEY HAD ¿NO IDEA WHAT TO DO.¿ THE PATIENT WAS REPORTEDLY SCHEDULED FOR SURGERY ON (B)(6) 2014. CULTURES WERE TAKEN AND REPORTEDLY SHOWED ¿STAPH INFECTION.¿ THE PATIENT NOTED THAT THEY ¿HAD NO SYMPTOMS OR INFLAMMATION¿ AND FELT THAT THE WOUND WAS ¿LEFT OPEN TOO LONG.¿ THE PATIENT REPORTEDLY WOULD HAVE ¿EVERYTHING PUT BACK¿ SIX MONTHS FOLLOWING THE EXPLANT. IT WAS FURTHER STATED THAT THE PATIENT HAD A ¿MESSED UP STIMULATOR IMPLANT,¿ BUT ¿DIDN¿T WANT TO GIVE IT UP.¿ A SUPPLEMENTAL WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307952 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention