BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2345652 · Received November 22, 2011

    Report

    Report Number
    3007566237-2011-09100
    Event Type
    Injury
    Date Received
    November 22, 2011
    Date of Event
    February 1, 2011
    Report Date
    November 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: OOI YC, SAULINO M, WILLIAMS KA, JR., SHARAN A. OBSERVATIONAL ANALYSIS OF SUCCESSFUL REIMPLANTATION OF EXPLANTED INTRATH ECAL DRUG DELIVERY SYSTEMS: A CASE SERIES. PMR : THE JOURNAL OF INJURY, FUNCTION, AND REHABILITATION. FEB 2011;3(2):175-178. DOI: 10.1016/J.PMRJ.2010.08.004. SUMMARY: THE AUTHORS REVIEWED 274 IMPLANT PROCEDURES THAT WERE PERFORMED INVOLVING 166 NEW PATIENTS. THEY EXAMINED PATIENTS WHO INITIALLY EXPERIENCED INFECTIOUS COMPLICATIONS REQUIRING INTRATHECAL DRUG DELIVERY SYSTEM (ITDDS) EXPLANTATION BETWEEN (B)(6) 2001 AND (B)(6) 2009. REPORTABLE EVENT: THE AUTHORS REPORT ON A (B)(6) FEMALE WITH MULTIPLE SCLEROSIS WHO WAS ORIGINALLY IMPLANTED ON THE LEFT ABDOMINAL SIDE (SUBCUTANEOUS). THE DEVICE WAS EXPLANTED DUE TO INFECTION; THE PATIENT WAS REIMPLANTED 3 MONTHS LATER ON THE RIGHT (SUBFASCIAL). FOLLOW UP AT 48 MONTHS REVEALED NO FURTHER COMPLICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention LEAD MODEL NEU_UNK_CATH LOT# UNK IMPLANTED: U