BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 5291943 · Received December 12, 2015

    Report

    Report Number
    3007566237-2015-03781
    Event Type
    Injury
    Date Received
    December 12, 2015
    Report Date
    March 30, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8637-20, PRODUCT TYPE :PUMP. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) IN (B)(6) REGARDING A PATIENT RECEIVING INTRATHECAL GABALON (CONCENTRATION UNKNOWN) WITH A DAILY DOSE OF 36 MCG VIA AN IMPLANTED PUMP. THE PUMP WAS IMPLANTED (B)(6) 2009 FOR HEREDITARY SPASTIC PARAPLEGIA. THE DOSING PERIOD WAS NOT PROVIDED. THE DATE OF INCIDENCE WAS UNKNOWN. THE PATIENT HAD A CATHETER TEAR AND WAS HOSPITALIZED. THE OUTCOME WAS NOT RECOVERED. THE EVENT WAS RELATED TO THE CATHETER AND UNRELATED TO THE PUMP, PROGRAMMER, PROCEDURE OR INVESTIGATIONAL DRUG. IT WAS FURTHER REPORTED PUMP IMPLANTATION AND REFILL WERE BOTH CARRIED OUT ON THE ITB PATIENT AT THE HOSPITAL. REGARDING THE PATIENT WHO WAS TRANSFERRED FROM THE HOSPITAL TO THE UNIVERSITY FOR A GENETIC ANALYSIS, THE LETTER OF INTRODUCTION FROM THE HOSPITAL SAID THE CATHETER MAY HAVE SNAPPED APART. THEY RECEIVED WORD THAT ON (B)(6) 2015, WHEN FIRST CONFIRMING IT WITHOUT A CONTRAST AGENT, THE CATHETER HAD COMPLETELY SNAPPED APART AT THE PLACE IT HAD BEEN INSERTED IN THE SPINE, AND THE SOMEWHAT SEPARATED CATHETER HAD BEEN LEFT IN THE SPINE (LUMBAR VERTEBRAE PORTION). IT WAS FURTHER REPORTED, THE PATIENT WAS HOSPITALIZED FOR GENETIC ANALYSIS. THE MEDICAL REFERRAL LETTER WHICH WAS WRITTEN BY THE PHYSICIAN OF THE HOSPITAL MENTIONED ABOUT THE POSSIBILITY OF CATHETER FRACTURE. IT WAS REPORTED THAT THE CATHETER WAS CHECKED WITHOUT USING CONTRAST MEDIUM ON (B)(6) 2015, AND IT WAS FOUND THAT THE CATHETER WAS FRACTURED, IN THE MIDDLE, COMPLETELY ON THE DRUG DOSING SITE OF THE SPINE AND THE CATHETER REMAINED IN THE SPINE(LUMBAR SPINE) ASIDE THE DRUG DOSING SITE. BECAUSE THE DOSE WAS RATHER LOW AND THERE HAD BEEN NO CHANGES TO THE EXTENT OF THE PATIENT'S SPASTICITY, THE UNIVERSITY REPLIED THAT, FOLLOWING THE COMPLETION OF THE GENETIC ANALYSIS PROCEDURES, THE PATIENT SHOULD RETURN TO THE HOSPITAL AND HAVE THE CATHETER REPLACED THERE. THE HOSPITAL WOULD TRANSFER THE PATIENT BACK TO GENERAL HOSPITAL AS SOON AS THE PROCEDURE FOR GENETIC ANALYSIS WAS FINISHED, AS THE DOSING AMOUNT WAS SMALL AND THERE WERE NO CHANGES IN THE DEGREE OF SPASTICITY. REPLACEMENT OF THE CATHETER WOULD BE DONE AT THE GENERAL HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THE ADVERSE EVENT/RELEVANT SPECIAL SITUATIONS WAS MARKED AS "SIDE EFFECTS" AND THE OUTCOME WAS UNKNOWN ADDITIONAL INFORMATION WAS REQUESTED FOR THE CONCENTRATION, LOT NUMBER, CONCOMITANT MEDICATIONS, RESOLUTION, CATHETER STATUS, HOSPITALIZATION AND SIDE EFFECT CLARIFICATION AS WELL. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CATHETER FRACTURE WAS CONFIRMED BY THE PLAIN RADIOGRAPH ON (B)(6) 2015. IT WAS UNKNOWN WHEN THE FRACTURE HAD OCCURRED. IT WAS NOTED THAT THERE WAS NO BIG CHANGE IN THE DRUG DOSE. THE ¿PUMP WAS PLACED¿ AS IT WAS UNTIL THE PUMP REPLACEMENT SINCE THERE HAD NOT BEEN AND EFFECT ON THE DAILY LIFE. IT WAS REPORTED THAT BOTH THE PUMP AND CATHETER REPLACEMENTS WERE CONDUCTED ON 2016-04-12 AND ISSUE WAS SOLVED. NO FURTHER COMPLICATIONS WERE REPORTED AND/OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS FURTHER REPORTED THAT THE CATHETER SPINAL CANAL RUPTURE WAS IDENTIFIED WITH A SIMPLE X-RAY AND THE TIME OF THE RUPTURE WAS UNKNOWN. THE INITIAL DAILY DOSE WAS 25.0 MCG/DAY. THE CATHETER TIP LOCATION WAS (T8) THORACIC VERTEBRA. NO FURTHER COMPLICATIONS WERE REPORTED AND/OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HCP VIA (B)(4). ON (B)(6) 2016 REPLACEMENT OF THE PUMP AND CATHETER WAS PERFORMED. THE ABDOMEN WAS OPENED AND IT WAS FOUND THAT THE CATHETER FROM THE V-WING ANCHOR WAS FRACTURED AS WAS EXPECTED. THE FRACTURED CATHETER (SPINAL CANAL) REMAINED IMPLANTED. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. IT WAS UNCLEAR WHEN THE FRACTURE OCCURRED. WHILE THE ISSUE OCCURRED, THE PRIMARY DISEASE DID NOT GET WORSE AND COULD BE CONTROLLED WITH A LOW DOSE OF APPROXIMATELY 35MCG. OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821295 INDURA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8711

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R