BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3881882 · Received June 18, 2014

    Report

    Report Number
    3007566237-2014-01702
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. PLEASE NOTE THAT SUPPLEMENTAL REPORT 2 WAS FILED WITH SPECIFIC SERIALS FOR THE PUMP, (B)(4), AND CATHETER, (B)(4), HOWEVER, THESE WERE INCORRECT. THE PUMP AND CATHETER ASSOCIATED WITH THIS EVENT REMAIN "UNKNOWN."

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED THE DEVICE SERIAL NUMBER. THE INITIAL MDR WAS FILED AS MFR REPORT #3007566237-2014-01702. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE 3004209178.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THERE WAS A PUMP REPLACEMENT WHERE THEY WERE UNABLE TO ASPIRATE THROUGH THE CAP. THE DRUG DELIVERED IN THE PUMP WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE FOR THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS NOTED THERE WAS A PUMP REPLACEMENT THE DAY PRIOR WHERE THEY WERE UNABLE TO ASPIRATE THROUGH THE CATHETER BUT WERE ABLE TO SUCCESSFULLY ABLE TO ASPIRATE THROUGH THE CATHETER ACCESS PORT (CAP). ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR EVENT CLARIFICATION, HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE. PLEASE NOTE THE PREVIOUS INFORMATION REPORTED IN THIS EVENT : "THERE WAS ALSO A PUMP REPLACEMENT THE DAY PRIOR WHERE THEY WERE UNABLE TO ASPIRATE THROUGH THE CAP" WAS NOT RELATED TO THIS EVENT. THIS WAS, HOWEVER, ACCURATELY CAPTURED IN MANUFACTURER REPORT #3004209178-2014-11804.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357211 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1