BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA SPINAL CATHETER

    MDR report key: 323392 · Received March 29, 2001

    Report

    Report Number
    6000030-2001-00103
    Event Type
    Injury
    Date Received
    March 29, 2001
    Date of Event
    September 1, 1999
    Report Date
    November 28, 2000
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A SYNCHROMED IMPLANTABLE INFUSION PUMP AND INDURA INTRASPINAL CATHETER IMPLANTED IN 1998 FOR TREATMENT OF NECK AND LEFT SHOULDER PAIN POST TRAUMA. THESE SYMPTOMS INCLUDED STIFF AND SORE LOWER LUMBAR SPINE PAIN AT L4-5 WITH CENTRAL DISC HERNIATION OBSERVED ON 1998. HCP REPORTS THE PATIENT EXPERIENCED BILATERAL BACK AND LEG PAIN ON 12/1998. THE PATIENT HAD BILATERAL LEG NUMBNESS (GREATER IN LEFT LEG THAN RIGHT LEG) NOTED ON 09/1999. PATIENT HAD AN MRI ON 09/1999. THE PATIENT HAD THE CATHETER REMOVED AND REPLACED AT A LOWER LEVEL IN 1999. OPERATIVE REPORT FINDINGS INCLUDED: GALLIM SCAN FOR WBC=14,700, SMAL BOWEL INFLAMMATORY, GRANULOMA, INFECTIONS OR NEOPLASTIC ORIGIN. THE COLON BIOPSY WAS NEGATIVE. THERE WAS NO SURGICAL INTERVENTION TO THE GRANULOMA. IN NOVEMBER OF 1999 THE PATIENT HAD THE CATHETER PULLED BACK FROM THE GRANULOMA. MRI WAS REPEATED IN 2000 AND 07/2000 WITH A "REDUCTION IN SIZE OF SMALL ENHANCING NODULE IN POSTERIOR ASPECT OF THECAL SAC AT T11". HCP REPORTS THAT THERE WAS NO MENTION OF L4-5 DISC HERNIATION PREVIOUSLY SEEN ON SCAN ON 05/1998. PATIENT OUTCOME: HCP REPORTS THAT THE PATIENT HAS WEAKNESS IN LEGS AND SOME NUMBNESS, POTENTIALLY COMPLEX REGIONAL PAIN SYNDROME. HCP REPORTS THAT THE NUMBNESS MAY BE FROM THE MORPHINE IN THE PUMP. PATIENT ALSO HAS LEG PARAESTHESIA AND SPASMS OF LOWER EXTREMITIES, WALKS WITH A CANE AND IS UNABLE TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14049 INDURA SPINAL CATHETER CATHETER LKK MEDTRONIC INC. 8703W L53270

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R SYNCHROMED IMPLANTABLE INFUSION PUMP,| MODEL 861718, IMPLANTED IN 1998 UNTIL DATE UNK.