BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 3181504 · Received June 17, 2013

    Report

    Report Number
    3006803715-2013-00006
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: DEVICE NOT AVAILABLE FOR EVAL. THE PUMP REMAINS IMPLANTED IN THE PT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PHYSICIAN WAS UNABLE TO INTERROGATE THE PUMP WITH THE PROGRAMMER. THE PHYSICIAN THOUGHT THERE MAY BE AN INFECTION SO HE SENT THE PT BACK TO THE GENERAL SURGEON, DR. (B)(6). IT WAS DETERMINED VIA ULTRASOUND THAT THERE WAS NO INFECTION SO THE PT WENT BACK TO THE OFFICE. ON (B)(6) 2013, THE PHYSICIAN DISCOVERED THAT THE PUMP HAD FLIPPED, WHICH RESULTED IN THE COMMUNICATION ISSUE WITH THE PROGRAMMER. THIS PHYSICIAN DID NOT USE THE SUTURE RING OR ANY SUTURES WHEN HE IMPLANTED THE PUMP. HE NEVER SUTURED OTHER PUMPS AND DID NOT WANT TO CHANGE HIS PROTOCOL. A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2013. THE PT IS NOT UNDERWEIGHT AND IS NOT KNOWN TO BE A TWIDDLER. ON (B)(6) 2013, THE PT UNDERWENT A REVISION SURGERY AND THE PHYSICIAN SECURED THE PUMP WITH TWO SUTURES IN THE FASCIA. THE PHYSICIAN REPORTED THAT THE PROBABLE CAUSE FOR THE PUMP FLIPPING WAS A LARGE SEROMA AT THE POCKET SITE. NO PT EFFECTS WERE REPORTED POST-OP. THERE WAS NO MALFUNCTION REPORTED FOR THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273628 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Other