BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3714747 · Received March 31, 2014

    Report

    Report Number
    3007566237-2014-00871
    Event Type
    Injury
    Date Received
    March 31, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED A LOW BATTERY RESET OF AN UNDETERMINED CAUSE. AS RECEIVED, THE PUMP LOGS INDICATED RESETS. DURING ANALYSIS, THE PUMP CONTINUED TO RESET. A HYBRID ISSUE WAS RULED OUT. NO FLUID, ELECTRO-CONDUCTIVE MATERIAL OR CORROSION RELATED ANOMALIES RESULTING IN A SHORT COULD BE FOUND. KNOWING THE TENDENCY FOR THE HIGH RESISTANCE ANOMALY TO ¿COME AND GO¿ AND FURTHER ANALYSIS NOT SHOWING ANY OTHER SEVERE ANOMALY, IT WAS DETERMINED THAT A HIGH RESISTANCE BATTERY WAS LIKELY THE CAUSE OF THE LOW BATTERY RESET.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N123026, IMPLANTED: 2007-(B)(6), PRODUCT TYPE ACCESSORY, PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT¿S PUMP WENT INTO MINIMUM RATE INFUSION MODE, ¿SAFE STATE OCCURRED¿ AND WOULD NOT COME OUT. PATIENT HAD EXPERIENCED LESS THAN 50% THERAPY RELIEF. THE PUMP WAS REPLACED. PATIENT STATUS AT TIME OF THIS REPORT WAS ¿ALIVE - NO INJURY¿. DRUG IN THE PUMP WAS DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187222 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention