BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2102710 · Received May 19, 2011

    Report

    Report Number
    3004209178-2011-03673
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    January 1, 2009
    Report Date
    April 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE PUMP (MODEL: 8637-40, (B)(4)) REVEALED A HYBRID ANOMALY. NO TELEMETRY WAS CONFIRMED REGARDING THE NEW PUMP. ONCE POWER WAS DISCONNECTED, TELEMETRY RESPONSE WAS POSSIBLE POST MILLING. HIGH CURRENT DRAIN WAS NOTED PRIOR TO DISCONNECTING THE POWER. AN (B)(6) SHOWED NO ANOMALIES. AN IR AND IP WERE CONDUCTED AFTER DISCONNECTING POWER, AND FUNCTION WAS FOUND TO BE POSSIBLE. THE CURRENT DRAIN WAS TESTED WITH NO TELEMETRY, AND A HIGH 412 UA VALUE WAS NOTED. AFTER THE POWER WAS DISCONNECTED, CURRENT WAS 8.3 UA; AND TELEMETRY WAS GOOD. BATTERY VOLTAGE WAS 3.027V. REGARDING S2 BATTERY VOLT A AND B FROM WAVEFORM TESTING, THE FOLLOWING WAS NOTED: A=3.08 B=3.02 60 MV DROP- PASS. REGARDING S2 BATTERY WAVEFORM RESISTANCE TESTING, THE FOLLOWING WAS INDICATED: BATTERY RESISTANCE AT WAVEFORM WAS 59 OHMS-PASS. M1 AND M2 MOTOR RESISTANCE TO CASE WERE GREATER THAN 200 M. MOTOR COIL RESISTANCE WAS 482 OHMS; AND THE MOTOR COIL PASSED TESTING. NO MOTOR STALL WAS NOTED. THE PUMP PASSED PATENCY TESTING. AN X-RAY CONFIRMED PROPELLANT. THE PUMP PASSED A VISUAL INSPECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2009, IT WAS INITIALLY REPORTED THAT THE PUMP WAS "DEAD ON ARRIVAL"; AND THAT IT WOULD NOT COMMUNICATE WITH MULTIPLE PROGRAMMERS. THE PUMP WAS NOT IMPLANTED IN A PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER STILL SEALED IN ITS PACKAGING. THE PUMP CONTAINED WATER (1,000.0 UL/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1