BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASCENDA

    MDR report key: 5293852 · Received December 14, 2015

    Report

    Report Number
    3007566237-2015-03784
    Event Type
    Death
    Date Received
    December 14, 2015
    Date of Event
    December 10, 2015
    Report Date
    December 10, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8637-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: PUMP. (B)(4). ANALYSIS OF THE CATHETER FOUND KINK ON CATHETER BODY. ANALYSIS OF THE CATHETER ALSO FOUND DAMAGE TO CATHETER BODY.

    Additional Manufacturer Narrative · 1

    \ADDITIONAL INFORMATION/DEVICE EVALUATION SUMMARY: ANALYSIS FOUND A KINK JUST DISTAL OF THE CATHETER TO CATHETER CONNECTOR ON THE SPINAL SEGMENT OF THE CATHETER AND A TORN TRANSITION TUBE ON THE PUMP SEGMENT OF THE CATHETER. WHEN THE KINK WAS BENT TO A TIGHT RADIUS DURING PRESSURE TESTING (OCCLUDED AT 1 PSI) THE CATHETER BECAME OCCLUDED. NO ANOMALIES WERE NOTED INSIDE THE SUTURELESS CONNECTOR CUP. CONCLUSION CODE IS NOT APPLICABLE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    INTERROGATION OF THE PUMP UPON RECEIPT INDICATED THAT THE PUMP WAS DELIVERING FENTANYL (1,500 MCG/ML AT 328.8 MCG/DAY) AND BUPIVACAINE (15 MG/ML AT 3.288 MG/DAY). THE PUMP RESERVOIR HAD 1 ML OF FLUID PRESENT. THE PUMP WAS IN THE SIMPLE CONTINUOUS INFUSION MODE WITH PATIENT ACTIVATED DOSING ACTIVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM HEALTHCARE PROVIDER. THE TOXICOLOGY REPORT WAS SENT BACK. THE COMPREHENSIVE BLOOD PANEL SHOWED THE PATIENT WAS POSITIVE FOR BENZODIAZEPINES, ALPRAZOLAM (ALPRAZOLAM QUANT: CONCENTRATION 31.8NG/ML, THERAPEUTIC RANGE IS 10-40), FENTANYL (FENTANYL QUANT: 62.3NG/ML, THERAPEUTIC RANGE 1-3), ANALGESTICS, TRAMADOL (TRAMADOL QUANT: 1490NG/ML, THERAPEUTIC RANGE 200-750), NORTRAMADOL (NORTRAMADOL QUANT: 203NG/ML, THERAPEUTIC RANGE-NOT ESTABLISTED), ANTIDEPRESSANTS, NORTRIPTYLINE (NORTRIPTYLINE QUANT: 292NG/ML, THERAPEUTIC RANGE 5-150), AND STIMULANTS (CAFFEINE-POSITIVE, ANALYTE WAS QUALITATIVELY POSITIVE BUT WAS NOT CONFIRMED BY AN ALTERNATE ANALYTICAL METHOD). THE URINE RANDOM TEST SHOWED POSITIVE FOR BENZODIAZEPINES, ALPRAZOLAM (ALPRAZOLAM QUANT: 460NG/ML), A-OH-ALPRAZOLAM ( A-OH-ALPRAZOLAM QUANT: 351NG/ML), FENTANYL (FENTANYL QUANT: 27.4NG/ML), NORFENTANYL (NORFENTANYL QUANT: 35.4NG/ML), TRAMDOL/METABOLITE (TRAMODOL QUANT: >1000NG/ML), AND NORTRAMADOL (NORTRAMADOL QUANT: >1000NG/ML).

    Description of Event or Problem · 1

    THE PATIENT PASSED AWAY ON (B)(6). THE CAUSE OF DEATH WAS NOT UNKNOWN. THE CATHETER WAS RETURNED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT RECEIVING MEDICATION VIA AN IMPLANTED PUMP. THE INDICATION FOR PUMP USE WAS NON-MALIGNANT PAIN/PANCREATITIS. PER THE MEDICAL EXAMINER, THE PATIENT HAD A VERY HIGH FENTANYL LEVEL AND HE COULDN'T DETERMINE WHY. THE PATIENT WAS FOUND DEAD BY HER ROOMMATE. SHE HAD JUST RECENTLY MOVED TO (B)(6) AND NO ONE KNEW MUCH ABOUT HER. THERE WAS NO RECORD THAT THE PUMP HAD BEEN REFILLED, BUT THERE WAS A GAP IN TIME BETWEEN (B)(6) 2015 WHEN SHE SAW THE PHYSICIAN IN (B)(6) THAT SHE HAD BEEN REFERRED TO AND HER DATE OF DEATH (B)(6) 2015. FOR PRECEDING EVENTS, SEE MANUFACTURER'S REPORT # 3004209178-2015-17629.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823595 ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8780

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Death| L