BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2931026 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00285
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS REVEALED MULTIPLE LOW BATTERY RESETS IN THE PUMP LOGS. THE BATTERY RESISTANCE WAS TESTED AND HAD A PASSING RESISTANCE OF 297 OHMS. CONSIDERING THIS PASSING RESISTANCE, THE PUMP RECEIVED FULL DESTRUCTIVE ANALYSIS TO CONFIRM IF ANY OTHER FLUID, ELECTRO CHEMICAL MIGRATION, OR CORROSION RELATED ANOMALY RESULTING IN A SHORT COULD BE FOUND. RESIDUE WAS FOUND IN THE PINION OF GEAR 2 AND ON THE LOWER PLATE OF GEAR 3. ALTHOUGH FURTHER ANALYSIS DID NOT SHOW ANY OTHER SEVERE ANOMALY, KNOWING THE INTERMITTENT TENDENCY FOR THE HIGH RESISTANCE ANOMALY IT WAS DETERMINED THAT A HIGH RESISTANCE BATTERY HAD CAUSED THE LOW BATTERY RESET TO OCCUR.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PUMP EXPLANT PLANNED. THE PUMP HAD A CRITICAL ALARM AND WAS FOUND TO BE IN SAFE STATE. THE PATIENT SUFFERED FROM MORPHINE WITHDRAWAL AND PAIN, THOUGH PATIENT OUTCOME WAS NOTATED AS "NO INJURY OR ADVERSE EVENT." THE DRUGS USED IN THIS SYSTEM WERE BACLOFEN AND MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36423 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention