BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1130885 · Received August 21, 2008

    Report

    Report Number
    3004209178-2008-05122
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE DEVICE IS INCLUDED IN THE SYNCHROMED II MISSING PROPELLANT RECALL AND PHYSICIAN COMMUNICATION (DATED 2008).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A SUDDEN CESSATION OF PAIN RELIEF AND SIGNS/SYMPTOMS OF ACUTE DRUG WITHDRAWAL WHICH INCLUDED TREMORS, NAUSEA, VOMITING, INCREASED PAIN, DIAPHORESIS AND DIARRHEA. THE PT WAS ADMITTED TO THE HOSP AND TREATED WITH UNSPECIFIED INTRAVENOUS NARCOTICS. IT WAS NOTED THAT THEY HAD SOME UNSPECIFIED ISSUES WITH THE PUMP AND IT WAS ONE OF THE PUMPS IN THE LIST OF SERIAL NUMBERS WITH NO PROPELLANT. THE PUMP WAS REPLACED. THE NEW DEVICE APPEARED TO BE FUNCTIONING WELL. THE PT WAS AT HOME RECOVERING FROM THE REPLACEMENT SURGERY. THE PUMP WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PROGRAMMER MODEL 8840 LOT # UNK| CATHETER MODEL 8731 LOT# B0379691K| IMPLANTED| EXPLANTED