BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3023143 · Received March 27, 2013

    Report

    Report Number
    9614453-2013-00576
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    September 24, 2024
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AND DECUBITUS ULCER, WHICH REQUIRED PHARMACOLOGICAL, MEDICAL, AND SURGICAL INTERVENTIONS. THE ONSET OR DIAGNOSIS OF THE INFECTION BEGAN "APPROXIMATELY" (B)(6) 2013. ACCORDING TO THE PATIENT, SHE NOTICED THE DEVICE COMING OUT OF THE POCKET THREE WEEKS PRIOR TO THE DATE OF THIS REPORT. SHE NOTED PUS DRAINAGE COMING OUT OF THE DEVICE POCKET. SHE WAS SUBSEQUENTLY PRESCRIBED ORAL ANTIBIOTICS, AMOXICILLIN, FOR TEN DAYS, WHICH WAS COMPLETE ON (B)(6) 2013. "AFTER COMPLETING THE TREATMENT", SHE HAD A PHYSICIAN APPOINTMENT FOR A "ROUTINE REVISION" WHEN THE HEALTH CARE PROVIDER, REPORTEDLY NOTICED THE DEVICE WAS "PARTIALLY COMING OUT OF THE SKIN THROUGH A 1 CM HOLE IN THE DEVICE POCKET." THE PATIENT HAD ANOTHER APPOINTMENT, "1 WEEK LATER" TO HAVE A SURGICAL REVISION OF THE DEVICE POCKET. DURING THE REVISION, IT WAS STATED THE DEVICE POCKET WAS "CLEANED." THE POCKET WAS "THOROUGHLY IRRIGATED WITH IODINE SOLUTION." THE DEVICE POCKET WAS "ENLARGED" FOR REASONS STATED "TO BETTER ACCOMMODATE THE DEVICE." A "FRIEDICH TECHNIQUE" WAS NOTED TO BE PERFORMED. INTRAOPERATIVELY, PROPHYLACTIC ANTIBIOTIC, CEFALOZIN, WAS ADMINISTERED. THE PATIENT CONTINUED ORAL ANTIBIOTIC TREATMENT, AMOXICILLIN, FOR TEN DAYS. IT WAS STATED THE PATIENT WAS "ADMITTED WITH A DECUBITUS AT THE DEVICE POCKET." IT WAS NOTED THE DEVICE ITSELF, REMAINED IMPLANTED IN THE PATIENT. IT WAS NOTED THAT A CULTURE WAS TAKEN ON (B)(6) 2013 FROM DEVICE POCKET. THE RESPONSIBLE ORGANISM HAD YET TO BE CONFIRMED AT THE TIME OF THIS REPORT. THE PATIENT'S STATUS WAS REPORTED AS ALIVE AND WITH INJURY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126083 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| R