BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2113830 · Received May 17, 2011

    Report

    Report Number
    3004209178-2011-03603
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    January 6, 2009
    Report Date
    April 27, 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). ANALYSIS OF THE PUMP (MODEL: 8637, (B)(4)) REVEALED A HYBRID ANOMALY. THE PUMP WAS RECEIVED IN AN UNOPENED BOX. A CORRUPTED CALIBRATION CONSTANT, AND PUMP MEMORY ERROR WAS INDICATED. THE MMC ANALYSIS DID NOT SHOW ANY ANOMALIES. MANY TESTS WERE CONDUCTED WHICH INVOLVED RESETTING THE CRITICAL DATA AND THE CALIBRATION CONSTANT CORRUPTED AT A SPECIFIC VOLTAGE OF 3.142. BATTERY VOLTAGE INITIALLY WAS 3.06 VOLTS. TESTING AT THESE VOLTAGES REVEALED NO CORRUPTION HAD OCCURRED. MMC TESTING, CONDUCTED TWICE, DID NOT SHOW ANY ANOMALIES. M1 AND M2 MOTOR RESISTANCE TO CASE TESTING DETERMINED THE FOLLOWING RESULTS: "OPEN." MOTOR COIL RESISTANCE WAS 492 OHMS. THE MOTOR COIL PASSED TESTING. THE PUMP PASSED PATENCY TESTING. THE PUMP ALSO PASSED A VISUAL INSPECTION. THE RESERVOIR WAS FOUND TO CONTAIN 15.0 MLS OF PF NORMAL SALINE.

    Description of Event or Problem · 1

    ON (B)(6) 2009, IT WAS INITIALLY REPORTED THAT A PUMP MEMORY ALARM OCCURRED. WHEN A MANUFACTURER REPRESENTATIVE TRIED READING THE PUMP, A "TELEMETRY CANCELLED" MESSAGE FOLLOWED BY A "PUMP MEMORY ERROR, CALIBRATION CONSTANT CORRUPTED" MESSAGE OCCURRED. ON (B)(6) 2009, IT WAS FURTHER REPORTED THAT A "PUMP MEMORY ERROR" OCCURRED UPON INTERROGATION OUT OF THE BOX. THERE WAS AN OPTION TO CANCEL TELEMETRY, AND IT THEN SHOWED "CALIBRATION CONSTANT CORRUPTED." THIS HAD OCCURRED IN THE OPERATING ROOM LAST NIGHT. THE PUMP WAS NOT IMPLANTED IN THE PATIENT, AS AN ALTERNATE WAS USED. THE PUMP WAS RETURNED TO THE MANUFACTURER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR PROGRAMMER: MODEL 8840, LOT# UNKNOWN| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNKNOWN