BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO MED II

    MDR report key: 1885203 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08423
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A "PUMP REPLACEMENT SURGERY" ON (B)(6) THE PUMP WAS EXPLANTED DUE TO WOUND DEHISCENCE; THERE WERE NO PLANS TO REIMPLANT THE PT DUE TO MEDICAL FRAILTY. NO WITHDRAWAL WAS NOTED AS THE DOSE WAS BEING WEANED. THE PUMP CONTAINED LIORESAL DILUTED TO 1000MCG/ML WITH DAILY DOSE OF 300MCG/DAY. IT WAS REPORTED THAT THE REASON FOR THE DEVICE REPLACEMENT ON (B)(6) WAS END OF BATTERY SERVICE. THOUGH IT WAS NOT ALARMING. REGARDING PT OUTCOME, IT WAS NOTED THAT THE PT HAD AN EXPLANT DUE TO WOUND DEHISCENCE. WITHDRAWAL WAS TREATED WITH INPATIENT HOSPITALIZATION AND ORAL BACLOFEN. THE PT WAS DISCHARGED HOME. NO FURTHER ITB (INTRATHECAL BACLOFEN) SURGERY WILL BE POSSIBLE AS THE PT HAD SUCH SEVERE MS AND WAS UNABLE TO TOLERATE ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO MED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization EXPLANTED:| LOT# NGH044088R| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# L78001| IMPLANTABLE INFUSION PUMP: MODEL 8627L18