BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063762 · Received April 14, 2011

    Report

    Report Number
    3004209178-2011-02821
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED RESPIRATORY DEPRESSION ASSOCIATED WITH ORAL HYDROMORPHONE OVERMEDICATION. THE PT BECAME APNEIC. THE PT WAS ADMITTED TO THE HOSPITAL. THE IMPLANTED PUMP, USED TO DELIVER HYDROMORPHONE AND BUPIVACAINE WAS SET TO MINIMUM RATE. THE SITUATION WAS LIFE THREATENING. THE PT'S BLOOD GAS LAB WORK REVEALED THE FOLLOWING: PH 7.32, PCO2: 56, PO2: 62, BICARBONATE: 28. THE PT RECOVERED WITHOUT SEQUELA.

    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 67 YR Hospitalization| L| R EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG022555N| CATHETER: MODEL 8709SC, LOT# N280436001| IMPLANTED: