BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDA

    MDR report key: 5348611 · Received January 6, 2016

    Report

    Report Number
    3007566237-2016-00071
    Event Type
    Injury
    Date Received
    January 6, 2016
    Report Date
    April 19, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PROBLEM: UPDATED/CORRECTED .

    Description of Event or Problem · 1

    ON (B)(6) 2015, INFORMATION WAS RECEIVED FROM A CONSUMER AND HEALTHCARE PROVIDER (HCP) REGARDING A (B)(6), FEMALE PATIENT WHO WAS RECEIVING DILAUDID (DOSE AND CONCENTRATION UNKNOWN) VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED FAILED BACK SYNDROME (1999). ON AN UNKNOWN DATE, AFTER A CATHETER REVISION ON (B)(6) 2015 THE CATHETER BROKE AND THE PATIENT WAS NOT GETTING ANY PAIN RELIEF. HER WHOLE QUALITY OF LIFE HAD CHANGED. IT WAS NOTED THE PATIENT'S PREVIOUS PUMPS (REPLACED DUE TO LONGEVITY) DID GREAT, BUT SHE HAD NOT HAD PAIN RELIEF SINCE THE 3RD PUMP WAS IMPLANTED AND IT WAS REALLY TAKING A TOLL ON THE PATIENT. IN (B)(6) 2015, THE HCP COULD NOT ASPIRATE THE SIDE PORT. IN (B)(6) 2016, THE PATIENT WAS SCHEDULED TO HAVE THE SYSTEM REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE CAUSE OF THE EVENT, TROUBLESHOOTING, ACTIONS/INTERVENTIONS AND THE EVENT'S OUTCOME, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON 2015-12-14, INFORMATION WAS RECEIVED FROM A CONSUMER AND HEALTHCARE PROVIDER (HCP) REGARDING A (B)(6)-YEAR-OLD, FEMALE PATIENT WHO WAS RECEIVING DILAUDID (DOSE AND CONCENTRATION UNKNOWN) VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED FAILED BACK SYNDROME (1999). ON AN UNKNOWN DATE, AFTER A CATHETER REVISION ON (B)(6) 2015, THE CATHETER BROKE AND THE PATIENT WAS NOT GETTING ANY PAIN RELIEF. HER WHOLE QUALITY OF LIFE HAD CHANGED. IT WAS NOTED THE PATIENT'S PREVIOUS PUMPS (REPLACED DUE TO LONGEVITY) DID GREAT, BUT SHE HAD NOT HAD PAIN RELIEF SINCE THE 3RD PUMP WAS IMPLANTED AND IT WAS REALLY TAKING A TOLL ON THE PATIENT. IN (B)(6) 2015, THE HCP COULD NOT ASPIRATE THE SIDE PORT. IN (B)(6) 2016, THE PATIENT WAS SCHEDULED TO HAVE THE SYSTEM REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE EVENT DATE, THE CAUSE OF THE EVENT, TROUBLESHOOTING, ACTIONS/INTERVENTIONS AND THE EVENT'S OUTCOME, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, INFORMATION WAS RECEIVED FROM A CONSUMER AND HEALTHCARE PROVIDER (HCP) REGARDING A (B)(6), FEMALE PATIENT WHO WAS RECEIVING DILAUDID (DOSE AND CONCENTRATION UNKNOWN) VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED FAILED BACK SYNDROME (1999). ON AN UNKNOWN DATE, AFTER A CATHETER REVISION ON (B)(6) 2015, THE CATHETER BROKE AND THE PATIENT WAS NOT GETTING ANY PAIN RELIEF. HER WHOLE QUALITY OF LIFE HAD CHANGED. IT WAS NOTED THE PATIENT'S PREVIOUS PUMPS (REPLACED DUE TO LONGEVITY) DID GREAT, BUT SHE HAD NOT HAD PAIN RELIEF SINCE THE 3RD PUMP WAS IMPLANTED AND IT WAS REALLY TAKING A TOLL ON THE PATIENT. IN (B)(6) 2015, THE HCP COULD NOT ASPIRATE THE SIDE PORT. IN (B)(6) 2016, THE PATIENT WAS SCHEDULED TO HAVE THE SYSTEM REMOVED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE "DISCS" ANYMORE AND IT WAS JUST VERTEBRAE. THE HCP WAS REVIEWING IF THE VERTEBRAE WERE WHAT WAS CRUSHING THE CATHETER. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE CAUSE OF THE EVENT, TROUBLESHOOTING, ACTIONS/INTERVENTIONS AND THE EVENT'S OUTCOME, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. DEVICE FAILURES INCLUDED CATHETER FAILURE. INJURIES INCLUDED WITHDRAWAL, PAIN, HOSPITALIZATION, AND SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7455 ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8780

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R