BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1943904 · Received December 28, 2010

    Report

    Report Number
    3004209178-2010-10799
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    September 30, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED "UNBEARABLE" PAIN WHEN HE WOKE UP IN THE RECOVERY ROOM FOLLOWING A PUMP IMPLANT ON (B)(6) 2010. THE PT WAS TAKEN BACK INTO SURGERY; THE CATHETER WAS REMOVED. THE PUMP REMAINED IMPLANTED WITH NO MEDICATION IN IT. THE PT REMAINED HOSPITALIZED FOR A WEEK. THE PT HAD THERAPY DURING THE SECOND WEEK. THE PT NOW HAS "DROPPED FOOT" AND CANNOT WALK FOR EXTENDED PERIODS OF TIME. THE REPORTER INDICATED THAT THERE MAY BE NERVE DAMAGE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R CATHETER: MODEL 8578, LOT #: N198679024| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT #: N198289028| IMPLANTED:| IMPLANTED: