BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2874761 · Received December 16, 2012

    Report

    Report Number
    3004209178-2012-11885
    Event Type
    Injury
    Date Received
    December 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # J10875R50, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S CATHETER WAS OCCLUDED. THE PATIENT HAD EXPERIENCED INCREASED PAIN AND NAUSEA, FOLLOWED BY WITHDRAWAL SYMPTOMS. IT WAS INDICATED DURING A CATHETER DYE STUDY PERFORMED ON (B)(6) 2012, THAT THERE WAS MINIMAL FLOW OF CEREBRAL SPINAL FLUID (CSF) AND THE PHYSICIAN COULD NOT ASPIRATE SUCCESSFULLY. UPON INTERROGATION, THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS AT 9 MONTHS, SO THE PHYSICIAN DECIDED TO REPLACE THE PUMP ALONG WITH A CATHETER REVISION. DURING REMOVAL OF THE CATHETER, THE DISTAL PORTION (DISTAL TO ANCHOR) HAD FRACTURED OFF AND THE CATHETER TIP HAD REMAINED IMPLANTED "IN THE DURA." THE NEW CATHETER WAS IMPLANTED AND CONNECTED TO THE PUMP. IT WAS REPORTED 4 DAYS POST-OPERATIVELY THAT THE PUMP WAS SET AT MINIMAL RATE AND LEFT WITH STERILE WATER IN THE RESERVOIR. IT WAS INDICATED, ROUTINELY THAT THE PATIENTS PUMP WOULD BE FILLED WITH DRUG POST-OPERATIVELY AT 10 DAYS. IT WAS LATER CONFIRMED THAT THE CAUSE OF THE EVENT WAS DUE TO A CATHETER OCCLUSION AND THE PUMP WAS REPLACED FOR NORMAL BATTERY DEPLETION. THE CATHETER OCCLUSION LOCATION WAS UNKNOWN. THE PATIENT'S OUTCOME WAS REPORTED AS NO INJURY. THE DRUG DELIVERED VIA PUMP WAS COMPOUNDED HYDROMORPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention