BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1000040 · Received February 15, 2008

    Report

    Report Number
    6000030-2008-00715
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 1, 2006
    Report Date
    January 16, 2008
    Manufacturer
    RICE CREEK MFG
    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

    FINAL DEVICE ANALYSIS REVEALS 3.2CM OF PROXIMAL CATHETER WITH THE PUMP CONNECTOR ATTACHED WAS RECEIVED. ACCEPTABLE CATHETER TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED THE FOLLOWING SYMPTOMS SINCE PUMP AND CATHETER REPLACEMENT IN 2006: RINGING IN THE EARS, CHANGE IN TASTE, VOICE CHANGE, PIN-PRICK SENSATIONS ON HER SCALP AND FOREHEAD, NUMBNESS IN THE UPPER EXTREMITIES. THE PUMP CONTAINED MORPHINE AND BACLOFEN. THE PT REPORTED THAT SHE WAS UNRESPONSIVE AND WAS NOT SURE IF SHE HAD A STROKE. THE PT ALSO REPORTED THE FOLLOWING SYMPTOMS, SINCE THE PUMP WAS IMPLANTED; ARMS LIKE NOODLES AND INABILITY TO SLEEP. THE SYMPTOMS SUBSIDE THEN WORSEN AFTER PUMP REFILLS. THE PT STATED THAT SHE WAS OK DURING THE DAY, BUT PROBLEMS ARISE WHEN SHE WAS RECLINING. THE HCP WAS AWARE OF THE SYMPTOMS AND LOWERED THE BACLOFEN DOSE BETWEEN REFILLS. THE PT STATED THAT THE TREATING PHYSICIAN WAS AT A LOSS AS TO WHY SHE WAS HAVING THESE SYMPTOMS. THE HCP REPORTED THAT THE PT'S SYMPTOMS WERE DUE TO A BAD DISK IN HER NECK AND NOT RELATED TO THE PUMP OR DRUGS IN PUMP. THE HCP LATER REPORTED THAT PT HAD THE PUMP AND CATHETER REPLACED ON APPROX SIX MONTHS LATER. DUE TO POOR PAIN CONTROL AND INCREASED SPASTICITY, A CATHETER DYE STUDY WAS PERFORMED AND REVEALED THAT THE CATHETER WAS OCCLUDED AS THEY WERE UNABLE TO ASPIRATE. SHE STATED THE PUMP WAS REPLACED BECAUSE THE PT WANTED THE 40CC PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT FOLLOWING IMPLANT OF A NEW PUMP AND CATHETER THEY TURNED ON THE PUMP AT THE HIGH DOSE FROM BEFORE AND THE PATIENT LOST THEIR EYE SIGHT. THE PATIENT HAD A STROKE. ON (B)(6) 2006, THE PUMP AND CATHETER WERE REPLACED. THE PATIENT HAD POOR PAIN CONTROL AND INCREASED SPASTICITY SO A CATHETER DYE STUDY WAS PERFORMED. THE PATIENT ALSO HAD LEFT ARM LOSS OF FINE MOTOR SKILLS. THE PATIENT WAS UNABLE TO HOLD A CAN OF POP OR OPEN A DOOR KNOB. THE LEFT ARM WAS ALWAYS A PURPLE/REDDISH COLOR AND THE BACK OF HER HEAD FELT VERY HEAVY ALL THE TIME AND SHE COULD NOT HOLD IT UP FOR VERY LONG. THE PATIENT'S HEAD WAS ALWAYS STIFF AND SHE FELT SHARP PAIN SHOOTING UP TO THE HEAD AND HAD AN INABILITY TO SLEEP. THE HCP FELT THAT THE PATIENT'S SYMPTOMS WERE DUE TO A BAD DISK IN HER NECK AND NOT RELATED TO THE PUMP OR DRUGS IN THE PUMP. IT WAS NOTED THAT THE SYMPTOMS SUBSIDED THEN WORSENED AFTER THE PUMP WAS REFILLED. THE PATIENT WAS OK DURING THE DAY, BUT PROBLEMS AROSE WHEN SHE WAS RECLINING. THE HCP LOWERED THE BACLOFEN DOSE BETWEEN REFILLS. THE PATIENT SAW THE HCP WHO HAD DONE A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND THEN RECOMMENDED A MAGNETIC RESONANCE IMAGE (MRI) TO SEE IF SHE HAD A TUMOR OR MASS. IN REGARDS TO THE SYMPTOMS (RINGING IN HER EARS, CHANGE IN TASTE, VOICE CHANGE, PIN-PRICK SENSATIONS ON SCALP AND FOREHEAD AND NUMBNESS IN THE UPPER EXTREMITIES) THE HCP INDICATED ON (B)(6) 2006 THAT THERE WAS NO ASSOCIATION TO THE PUMP AND NO DEVICE TROUBLESHOOTING WAS REQUIRED - THE PATIENT HAD RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8709AA N064836018

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R IMPLANTED| EXPLANTED