BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3092448 · Received May 3, 2013

    Report

    Report Number
    3007566237-2013-01525
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, LOT# J11207R58, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VOLUME DISCREPANCY OCCURRED DURING PUMP REFILL. THE REPORTER STATED THAT DURING THE PATIENT'S LAST REFILL THE ACTUAL RESIDUAL VOLUME (ARV) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV); HOWEVER,EXACT VALUES WERE NOT PROVIDED. THE REPORTER WAS CURRENTLY PERFORMING A ROTOR STUDY AND A DYE STUDY. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT HAS SPASMS BEFORE HAVING THE PUMP REFILLED BUT THEY USUALLY RESOLVE AFTER THE PUMP REFILL. THE CAUSE OF THE VOLUME DISCREPANCY REMAINED UNKNOWN. THE REPORTER STATED THAT THE PATIENT SEEMED TO BE DOING FINE POST TROUBLESHOOTING; HOWEVER, WAS UNCERTAIN OF HOW THE PATIENT WAS DOING AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193582 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1