BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDURA

    MDR report key: 1062746 · Received June 3, 2008

    Report

    Report Number
    2182207-2008-02953
    Event Type
    Malfunction
    Date Received
    June 3, 2008
    Date of Event
    March 31, 2008
    Report Date
    May 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED SLICE CUTS 1.3 CM AND 6.7 CM FROM THE DISTAL END OF THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD BEEN SCHEDULED TO HAVE THE PUMP REPLACED DUE TO EOL IN FEBRUARY, BUT DUE TO POOR PULMONARY STATUS AND SEIZURES, IT WAS NOT PERFORMED. APPROX TWO DAYS FOLLOWING THE PUMP AND PROXIMAL CATHETER REPLACEMENT, THE PT PRESENTED WITH SIGNS OF WITHDRAWAL, SPECIFICALLY SEIZURES, INCREASED IRRITABILITY, HYPOTENSION, HYPERTERMIA (107 DEGREES FAHRENHEIT), AND TACHYCARDIA. THE PT ALSO HAD MARKEDLY ELEVATED CPK LEVELS, ELEVATED BUN, ELEVATED INR, AND NORMAL PULSE OXIMETRY WITH 2L OXYGEN VIA NASAL CANNULA. THE PT HAD NO EVIDENCE OF RESPIRATORY DISTRESS. THE HCP INTERROGATED THE PUMP. DUE TO THE WITHDRAWAL SYMPTOMS, THE DOSE WAS INCREASED WITH NO IMPROVEMENT IN SYMPTOMS. THE HCP NOTED THAT SHE WAS UNABLE TO ASPIRATE ANY CONTENTS FROM THE CATHETER ACCESS PORT. THE PUMP WAS EMPTIED AND A VOLUME DISCREPANCY WAS NOTED WITH MORE VOLUME THAN EXPECTED. THE DRUG WAS THEN REMOVED AND A NEW REFILL KIT USED TO ENSURE THE CORRECT CONCENTRATION. THE PT WAS GIVEN FENTANYL AND VERSED IV TO CONTROL SEIZURES AND ONCE THIS IMPROVED, THE PT WAS TAKEN TO SURGERY. DURING THE CATHETER REVISION SURGERY THE HCP NOTED THAT THERE WAS NO CSF FLOW WHEN THE CATHETER WAS DISCONNECTED FROM THE PUMP, BUT THERE WAS CSF FLOW WHEN THE SUTURELESS CONNECTOR WAS DISCONNECTED. A NEW CONNECTOR WAS APPLIED AND GOOD CSF FLOW WAS ESTABLISHED. IT WAS ESTIMATED THAT THE PT WAS WITHOUT BACLOFEN FOR 3-7 DAYS. FOLLOWING SURGERY, THE PT'S DOSE WAS DECREASED FROM 1500 MCG/DAY TO 600 MCG/DAY. PHYSICAL EXAMINATION REVEALED HYPOTONIA OF ALL EXTREMITIES. TWENTY-FOUR HOURS LATER, THE PT WAS NOT ALERT AND REMAINED UNRESPONSIVE. FENTANYL AND VERSED HAD BEEN DISCONTINUED. THE NEXT DAY THE PT'S DOSE WAS DECREASED TO 300MCG/DAY. THE PT BECAME ALERT AND WAS KEPT IN THE PEDIATRIC ICU FOR OBSERVATION. FOUR DAYS LATER, THE HCP NOTED THE PT EXHIBITED INCREASED TONE, HYPERREFLEXIA, AND CLONUS. THE PT'S BACLOFEN DOSE WAS INCREASED (DOSE UNSPECIFIED). THE NEXT MORNING, THE PT BECAME AGITATED, HIS BLOOD PRESSURE INCREASED, AND HE WENT INTO RESPIRATORY ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, BUT THE PT REMAINED UNRESPONSIVE REQUIRING A DOPAMINE INFUSION. HE ALSO HAD SECOND-THIRD DEGREE SINUS HEART BLOCK. THE PT'S INR WAS 24. THE PT WAS DIAGNOSED WITH DISSEMINATED INTRAVASULAR COAGULATION (DIC). THE PT LATER EXPIRED. AN AUTOPSY WAS PERFORMED. THE PATHOLOGIST IS AWAITING FINAL ANALYSIS OF THE DEVICE. THE PRELIMINARY CAUSE OF DEATH WAS DIC. THE DRUG CONTAINED IN THE PT'S PUMP WAS LIORESAL 2000 MCG/ML. SEE MFR REPORT# 218220720082143.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC NEUROMODULATION 8709SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death| H| L| R EXPLANTED| PUMP MODEL 8637| PROGRAMMER MODEL 8840 LOT # UNK| IMPLANTED