BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2905569 · Received January 9, 2013

    Report

    Report Number
    3007566237-2013-00097
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    PRODUCT ID 8711, LOT# J10918R27, IMPLANTED: (B)(6) 2001, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP REVEALED MOTOR CORROSION, WEAR, AND/OR LUBRICATION AS WELL AS A GEAR TRAIN ANOMALY. THE PUMP WAS STALLED UPON ARRIVAL AND STALLED AGAIN DURING A DISPENSE TEST. RESIDUE WAS FOUND ON THE LOWER SHAFT AND THE LOWER BRIDGE JEWEL OF GEAR TWO. IT WAS THOUGHT THAT THIS HAD CAUSED THE STALL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED VIA MANUFACTURER'S REPORT # 3007566237-2013-00280: [THE PATIENT STATED THAT HER PUMP HAD TO BE EXPLANTED BECAUSE IT WAS 'SETTING TO SAFE STATE.' TROUBLESHOOTING WAS LIMITED AS THE PUMP LOGS WERE UNKNOWN AS OF THE DATE OF THIS REPORT.] NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REPEATED, INTERMITTENT MOTOR STALLS OCCURRED. THE PUMP WAS INTERROGATED AND IT WAS CONFIRMED THAT THE PUMP HAD STALLED AND RECOVERED FIVE TIMES AT VARYING INTERVALS SINCE (B)(6), 2012. THE REPORTER RULED OUT EXPOSURE TO MAGNETS AND THE CAUSE OF THE MOTOR STALLS WAS UNKNOWN. NO ROTOR STUDY OR DYE STUDY WERE PERFORMED. THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS. THE PATIENT PRESENTED TO THE MANAGING DOCTOR'S OFFICE ON (B)(6) WITH COMPLAINTS OF ITCHING AND SPASTICITY. THE PATIENT HAD BEEN TO THE EMERGENCY ROOM (ER) ON DECEMBER 16 WITH SIMILAR COMPLAINTS, WAS TREATED WITH BENADRYL AND WAS DISCHARGED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL ON (B)(6). THE PUMP WAS REPLACED ON (B)(6) DUE TO MOTOR STALL. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN (BACLOFEN). A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11544 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Hospitalization| R