BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3033215 · Received April 3, 2013

    Report

    Report Number
    3007566237-2013-01011
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS PREVIOUSLY REPORTED IN MANUFACTURER'S REPORT #3007566237-2012-01825: [IT WAS REPORTED THAT THE PATIENT'S CATHETER WAS NOT "ASPIRATABLE." THE CATHETER WAS REPLACED AT THE TIME THE PUMP WAS REPLACED FOR END OF LIFE (EOL). IT WAS UNKNOWN WHAT MEDICATIONS WERE USED IN THE DEVICE SYSTEM. THE PATIENT LATER REPORTED THAT PRIOR TO HER SYSTEM REPLACEMENT IN (B)(6) 2012, THE PATIENT'S HEALTHCARE PROVIDER SUSPECTED THAT THERE WAS SOMETHING THAT WAS NOT FUNCTIONING PROPERLY. AFTER PERFORMING "SOME SORT OF DIAGNOSTIC ON IT," THEY THOUGHT THAT "THERE MIGHT BE A KINK IN THE CATHETER LINE". THE PATIENT STATED "IT SEEMED OBVIOUS THAT SOMETHING WAS WRONG BECAUSE HER SPASTICITY WAS SO BAD SHE COULD HARDLY WALK". THE PATIENT'S OUTCOME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED. PLEASE SEE MANUFACTURER'S REPORT #3004209178-2012-03460 FOR INFORMATION PERTAINING TO A CATHETER DISLODGEMENT AND PATIENT WITHDRAWAL FOLLOWING THIS REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136699 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention