BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4103025 · Received September 19, 2014

    Report

    Report Number
    3007566237-2014-02643
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    July 3, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS SINCE HER REFILL ON (B)(6) 2014 WITH HER MANAGING HEALTH CARE PROVIDER. THE PATIENT THOUGHT THE PHYSICIAN INCREASED ¿IT¿ AT THE PUMP REFILL ON (B)(6) AND THAT SHE FELT FUNNY WHEN SHE WAS IN THE OFFICE. SHE STATED SOMETHING HAD HAPPENED TO HER AND SHE COULD NOT EVEN TALK. SHE WAS EXPERIENCING ¿SERIOUS¿ PAIN THAT WAS OUT OF THE ORDINARY. THE PATIENT HAD SEEN HER MANAGING PHYSICIAN ABOUT HER SYMPTOMS WHEN SHE WAS IN THE HOSPITAL LAST WEEK. THE PHYSICIAN JUST PUT ¿THAT LITTLE THING UP TO MY PUMP¿ AND TOLD THE PATIENT TO KEEP ¿THE APPOINTMENT.¿ AN INQUIRY WAS MADE REGARDING THE APPOINTMENT MENTIONED. THE PATIENT STATED THE MANAGING PHYSICIAN ¿INCREASED THE DOSE ON THE PUMP TO WHAT IT WAS, A HIGHER DOSE, AND THEN WHEN I WENT TO HIS OFFICE REALLY SICK HE DECREASED THE PUMP MEDICINE.¿ THAT WAS THE LAST TIME THE PATIENT SPOKE TO THE PHYSICIAN ABOUT ¿ANYTHING.¿ INQUIRY WAS MADE WHEN THE PHYSICIAN DECREASED THE PUMP AND THE PATIENT STATED SHE WAS SO CONFUSED AND STATED ¿I CAN¿T EVEN THINK. I¿M SICK.¿ THE PATIENT DID NOT KNOW THE CURRENT OR PREVIOUS DOSES OR CONCENTRATIONS. SHE STATED THAT THE PUMP HAD BEEN INCREASED BY 8% AND IT WAS DECREASED BY 4% BECAUSE THE PATIENT WAS FEELING SICK AND THE SYMPTOMS DID NOT GO AWAY. THIS DEVICE SYSTEM DELIVERED DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO VERIFY EVENT DETAILS, RESOLUTION, PATIENT STATUS AND OUTCOME. HOWEVER, NO INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582567 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R