BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4012397 · Received August 15, 2014

    Report

    Report Number
    3007566237-2014-02285
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID NEU_UNKNOWN_PUMP, SERIAL# UNKNOWN, PRODUCT TYPE: PUMP; PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS REPLACED LAST MONTH AND THE WOUND WAS OPEN, LEAVING THE PUMP EXPOSED. THE WOUND WAS NOT BELIEVED TO BE INFECTED. IT WAS LATER REPORTED THE ENTIRE SYSTEM, PUMP AND CATHETER, WAS EXPLANTED ON (B)(6) 2014. THE OPEN WOUND WAS ON THE BACK WHERE THE INCISION WAS MADE TO INSERT THE CATHETER. THERE WAS PUS. THE PUS WAS CULTURED AND CONFIRMED AN INFECTION. THE TYPE OF INFECTION WAS UNKNOWN AND IT WAS NOT KNOWN IF ANTIBIOTICS WERE GIVEN. THE PUMP WAS BEING USED TO DELIVER MORPHINE AND BUPIVACAINE. THE PATIENT HAD NO PERTINENT MEDICAL HISTORY SHE WAS AWARE OF. THE CAUSE WAS UNDETERMINED BUT IT WAS REPORTED THE LIKELY CAUSE WAS POOR CLOSURE OF THE WOUND. THE PATIENT DID NOT HAVE AUTOIMMUNE ISSUES OR A LOW IMMUNE SYSTEM. THERE WAS NO PLAN TO RE-IMPLANT AS OF (B)(6) 2014. THE PUMP AND CATHETER WERE DISCARDED. IT WAS ALSO REPORTED THE PATIENT HAD WOUND DEHISCENCE AT THE PUMP POCKET INITIALLY, BUT THAT HEALED WITH NO ISSUE. SOMETIME LATER THE PATIENT HAD WOUND DEHISCENCE AT THE MIDLINE INCISION AND NOTHING THAT WAS DONE HELPED IT HEAL. IT LED TO INFECTION. THE PATIENT HAD A HISTORY OF DIABETES, PARAPLEGIA, OBESITY, AND A HISTORY OF HAVING NON-PUMP RELATED WOUNDS THAT WERE HARD TO HEAL. THE PATIENT WAS AT A NURSING HOME AND IT WAS SUSPECT THAT LACK OF WOUND CARE LED TO THE INFECTION. THERE WERE SEVERAL TIMES THE WOUND WAS NOT BANDAGED AT ALL AND THE PATIENT NEVER WORE AN ABDOMINAL BINDER. POOR POST-OPERATIVE CARE WAS REPORTED. THE PATIENT ¿WOULD LOVE¿ ANOTHER PUMP. THE PATIENT WAS DOING WELL AND THE INFECTION WAS HEALING. THE PATIENT RESPONDED TO THE PUMP AND PHYSICAL THERAPY VERY WELL AND WAS ABLE TO STAND FOR THE FIRST TIME IN 20 YEARS AND TOOK 3 STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489323 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention