BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2251595 · Received September 14, 2011

    Report

    Report Number
    3004209178-2011-07823
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 26, 2011
    Report Date
    September 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD HIS PUMP SYSTEM EXPLANTED DUE TO INFECTION. AFTER EXPLANTATION, THE MEDICATION WAS ASPIRATED FOR WASTE. A VOLUME DISCREPANCY WAS ALSO REPORTED. THE EXPECTED RESERVOIR VOLUME (ERV) WAS 18 MLS, BUT THE ACTUAL RESERVOIR VOLUME(ARV) WAS 36 MLS. PER THE REPORTER, THE PT "NEVER RECEIVED ANY MEDICATION SINCE IMPLANTATION (B)(6) 2011." THE PUMP WAS PROGRAMMED TO ADMINISTER DILAUDID (CONCENTRATION 5.0 MG/ML; DAILY DOSE OF 0.0310 MG/DAY) AND BUPIVACAINE (CONCENTRATION 6.7 MG/ML; DAILY DOSE OF 0.0415 MG/DAY). NO PT INJURY WAS REPORTED. THE PT RECOVERED WITHOUT SEQUELA. ADD'L INFO 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
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N289604005| PROGRAMMER: MODEL 8835, LOT# NPG023615N