BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2993224 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03459
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL NEU_UNKNOWN_CATH SERIAL# UNKNOWN, PHYSICIAN PROGRAMMER: MODEL 8840 LOT# SERIAL# UNKNOWN, IMPLANTED: NA, EXPLANTED: NA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP INTERROGATED "FINE" IN THE BOX, BUT GOT INVALID TELEMETRY ONCE IMPLANTED. THE DEVICE WAS REMOVED, SET IN STERILE FIELD, INTERROGATED, STILL GOT INVALID TELEMETRY. A SECOND PHYSICIAN PROGRAMMER WAS USED WITH THE SAME RESULTS. A SECOND POCKET WAS FORMED. INITIALLY, IT WAS THOUGHT THERE WAS NO ELECTROMAGNETIC INTERFERENCE (EMI) PRESENT BUT IT WAS LATER CONFIRMED THAT NEW LIGHTS WERE INSTALLED IN THE OR AND WHEN SET AT FULL STRENGTH TELEMETRY COULD NOT BE COMPLETED. THERE WERE NO TELEMETRY TROUBLES WHEN THE LIGHTS WERE SHUT OFF. NO PATIENT SYMPTOMS WERE REPORTED. THE SYSTEM WAS USED TO INFUSE DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT EVERYTHING RESOLVED WHEN LIGHTS WERE TURNED OUT. THE LIGHTS CREATED AN ELECTROMAGNETIC FIELD THAT INTERRUPTED TELEMETRY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97587 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Other