BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2090885 · Received April 26, 2011

    Report

    Report Number
    3007566237-2011-03107
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    August 1, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON(B)(6) 2010 THAT THE PUMP ALARM WAS HEARD BUT NOT CONFIRMED BY TELEMETRY. THE CRITICAL ALARM WAS SOUNDING EVERY 30 MINUTES; THE ALARM WAS OCCURRING OVER THE LAST 5-6 DAYS. THE PT WAS ASYMPTOMATIC AND PLANNED TO SEE THE HCP ON (B)(6) 2010. THE HCP INDICATED THE PUMP CONTAINED PRIALT AND HYDROMORPHONE. THE PUMP WAS INTERROGATED ON (B)(6) 2010. THE LOW AND EMPTY RESERVOIR ALARMS OCCURRED. THE LOGS SHOWED THE PUMP WAS EMPTY; IN FACT THERE WAS 6MLS IN THE RESERVOIR. AS OF THAT DATE, THE PUMP SHOULD HAVE HAD 6 MLS IN THE RESERVOIR. THERE WAS ALSO A DISCREPANCY IN THE EVENT LOGS REGARDING THE TIME OF THE LAST CHANGE TO THE PUMP PROGRAMMING. THE LOGS FROM (B)(6) 2010, WHERE THE PUMP WAS PROGRAMMED AT THE CLEVELAND CLINIC, SHOWED THE NEW PUMP SETTINGS OCCURRED (B)(6) 2010 AT 09:02. THE RESERVOIR VOLUME WAS 20 ML AND THE LOW RESERVOIR ALARM DATE WAS TO OCCUR (B)(6) 2010. THE LOGS FROM (B)(6) 2010, WHERE THE PUMP WAS READ AT THE "PCPM", SHOWED THE LAST CHANGE TO THE PUMP OCCURRED (B)(6) 2010 AT 08:02 (ONE HOUR EARLIER). THE PT EXPERIENCED NO SYMPTOMS AND THE PT OUTCOME WAS REPORTED AS "NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK