BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2250641 · Received September 13, 2011

    Report

    Report Number
    3007566237-2011-07800
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    September 2, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOWING SYSTEM IMPLANT IN (B)(6) 2011, THE PT EXPERIENCED "GOOD EFFECT" 2 WEEKS AFTER IMPLANT. THE EFFECT THEN "SLOWLY DISAPPEARED". THE MEDICATION DOSE WAS INCREASED, BUT THE EFFECT WAS NOT BETTER. DURING THE FIRST PUMP REFILL PROCEDURE ON (B)(6) 2011, THE NURSE NOTICED THAT THE PROGRAMMER STATED THERE SHOULD HAVE BEEN 4.5 MLS IN THE PUMP; BUT WHEN THE DRUG WAS ASPIRATED FROM THE RESERVOIR, 35 MLS OF ACTUAL DRUG WAS ASPIRATED. AN X-RAY OF THE PUMP SYSTEM WAS PERFORMED; IT WAS NOTED THAT THE CATHETER "HAD GONE OUT OF THE SPINAL CANAL, SAW THE DRUG WAS NOT DELIVERED IN THE SPINAL CANAL." THE CATHETER WAS REPLACED. THE PT'S OUTCOME WAS REPORTED AS 'GOOD, PT STARTS TO GET EFFECT AGAIN OF THE DRUG." DRUG DELIVERED WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL 8709SC, LOT# 0204635246| IMPLANTED:| EXPLANTED: