BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1850828 · Received September 28, 2010

    Report

    Report Number
    3007566237-2010-07387
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS REQUESTED BUT NOT RECEIVED AT TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS AFTER A REFILL WAS MISSED AND THE PATIENT'S PUMP ALMOST RAN DRY. THE PATIENT'S HEALTHCARE PROVIDER (HCP), THEN, REFILLED THE PT'S PUMP ON (B)(6)2010, AND DECREASED THE MEDICATION DOSAGE FROM 7.0 MG/DAY TO 1.25 MG/DAY. THE PT WAS TO BE SLOWLY TITRATED TO A SAFE THERAPEUTIC DOSE. NO FURTHER INFO REGARDING THE PT'S PUMP MEDICATION TYPE AND CONCENTRATION WAS KNOWN. THE HCP PROVIDED (ORAL) MEDICATION TO THE PATIENT TO DEAL WITH THE WITHDRAWAL SYMPTOMS. THE PT ATTEMPTED TO GIVE A BOLUS OF MEDICATION VIA THE PUMP. IT WAS STATED THAT THE MFR REP DID NOT PROGRAM THE PT'S MONITOR (PTM) TO PROVIDE BOLUS DOSING. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention CATHETER: MODEL 8709, LOT# N064788016| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8832, LOT# NJG002776N| IMPLANTED:| EXPLANTED: