BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1843640 · Received September 22, 2010

    Report

    Report Number
    3007566237-2010-07170
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP HAD A CONFIRMED MOTOR STALL, AS NOTED IN THE EVENT LOGS, WITH NO MOTOR STALL RECOVERY RECORDED. THE LOGS SHOWED MULTIPLE PREVIOUS MOTOR STALLS AND RECOVERIES. THE PT'S HEALTHCARE PROVIDER (HCP) DID A CATHETER ACCESS PORT (CAP) DYE STUDY ON (B)(6) 2010, DUE TO THE PT EXPERIENCING BOTH UNDERDOSING AND OVERDOSING SYMPTOMS WITH INCREASED BASELINE PAIN. THE PT HAD NO ELECTROMAGNETIC INTERFERENCE (EMI) OR MAGNETIC INTERACTION. THE PT'S PUMP WAS TO BE REPLACED. THE PT'S PUMP CONTAINED DILAUDID, BUPIVACAINE, AND BACLOFEN. THERE WAS NO INFO PROVIDED REGARDING THE CONCENTRATION OR DOSE OF THE PT'S PUMP MEDICATIONS. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED, BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 Required Intervention IMPLANTED:| CATHETER: MODEL 8711, LOT # N091107003| CATHETER: MODEL 8709, LOT # L64341| EXPLANTED:| EXPLANTED:| IMPLANTED: