BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 7411189 · Received April 10, 2018

    Report

    Report Number
    3007566237-2018-01027
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    March 21, 2018
    Report Date
    April 10, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE INFUSION PUMP FOR AN UNKNOWN INDICATION FOR USE. IT WAS REPORTED THAT A MOTOR STALL WAS SEEN AT INITIAL INTERROGATION AND IT WAS UNKNOWN IF THE PATIENT RECENTLY HAD AN MRI. THE LOGS SHOWED A MOTOR STALL AND RECOVERY ON (B)(6) 2018 AND THEN ANOTHER STALL WITH NO RECOVERY ON (B)(6) 2018. THEY PLANNED TO REPLACE THE PUMP ON (B)(6) 2018. NO SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE EXPECTED OR ANTICIPATED. ON (B)(6) 2018 E1 (HCP, REP): ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CAUSE OF THE MOTOR STALL AND RECOVERY ON (B)(6) 2108 AND THEN ANOTHER STALL WITH NO RECOVERY ON (B)(6) 2018 WAS UNKNOWN. NO KNOWN ENVIRONMENTAL FACTORS WERE REPORTED. AS AN ACTION/INTERVENTION TAKEN TO RESOLVE THE MOTOR STALLS, THE PUMP WAS INTERROGATED BY THE HCP AND REPLACEMENT OCCURRED ON (B)(6) 2018 WHICH RESOLVED THE ISSUE. THE PUMP WAS REQUESTED FOR RETURN TO THE MANUFACTURER FOR ANALYSIS BUT WAS DENIED AND DISCARDED BY THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259580 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention