BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2070156 · Received April 25, 2011

    Report

    Report Number
    3004209178-2011-03066
    Event Type
    Injury
    Date Received
    April 25, 2011
    Report Date
    April 6, 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PRE-EXISTING PAIN. IMAGING FOUND THAT THE INTRATHECAL CATHETER WAS DISCONNECTED. THE PT UNDERWENT A SURGICAL REVISION. THE PT RECOVERED WITHOUT SEQUELA. THE DRUG CONTAINED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED.

    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 64 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8709, LOT# J10863R53| IMPLANTED: