BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2180992 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05699
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN OVERDOSE WAS REPORTED WITH SYMPTOMS OF DROWSINESS, DIZZINESS, LIGHTHEADEDNESS AND SLOW SHALLOW BREATHING. THE EVENT OCCURRED FOLLOWING A REFILL SESSION. IT WAS UNK WHETHER THE PROCEDURE CAUSED THE PROBLEM. THE REFILL WAS INCREASED BY 10% BY THE NURSE UPON PT'S REQUEST, HOWEVER, THE PT'S LEGAL GUARDIAN HAD INDICATED TO THE NURSE THAT SHE DID NOT WANT THE FLOW RATE INCREASED. THE REFILL NURSE HAD INSTRUCTED THEM TO GO TO THE EMERGENCY ROOM. NO FURTHER INFO WAS AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR CATHETER: MODEL 8596, LOT# B008281N08| CATHETER: MODEL 8709, LOT# J55516R13| IMPLANTED:| CATHETER: MODEL 8578, LOT# N269745013| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: