BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093650 · Received May 12, 2011

    Report

    Report Number
    3004209178-2011-03442
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES HAVE BEEN RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT HAD A DISPLACED INTRATHECAL CATHETER. THE PUMP AND CATHETER WERE REPLACED. DURING THE PUMP AND CATHETER REPLACEMENT, THE "CATHETER WAS LODGED IN THE SPINAL CORD". THE PT WAS HAVING NUMBNESS ON HER LEFT SIDE. THE PHYSICIAN PLANNED TO CONSULT WITH A NEUROSURGEON. IT WAS THOUGHT THAT THE CATHETER MIGHT BE REMOVED ON (B)(6) 2011. THE RETURN PAPERWORK INDICATED THAT THERE WAS NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE (60 MG/ML) AND BUPIVACAINE (1.5 MG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention ACCESSORY: MODEL 8590-1, LOT# N087452| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N108692005| IMPLANTED: