BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1961079 · Received January 12, 2011

    Report

    Report Number
    3004209178-2011-00298
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 7, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS DUE FOR A PUMP REFILL ON (B)(6) 2010 BUT HER PHYSICIAN WAS NO LONGER ABLE TO FILL PUMPS AND DUE TO THAT, HER PUMP WENT DRY. THE PT WENT THROUGH EXTREME WITHDRAWAL AND HAD TO BE ADMITTED TO A "DETOX" CENTER DUE TO THE SEVERITY OF THE WITHDRAWAL SYMPTOMS. THE PT'S PUMP CURRENTLY DID NOT HAVE MEDICATION IN IT. SHE WAS SCHEDULED FOR ANOTHER PUMP REFILL ON (B)(6) 2011. THE PT WAS CONSIDERING HAVING HER PUMP EXPLANTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R EXPLANTED:| CATHETER: MODEL CATHETER, LOT #: UNK| IMPLANTED: