BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3030083 · Received April 2, 2013

    Report

    Report Number
    3007566237-2013-00965
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    September 29, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703, LOT# J94142142, IMPLANTED: (B)(6) 1995. PRODUCT TYPE: CATHETER: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8703, LOT# J94142142, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. CORRECTION: ALL PREVIOUSLY REPORTED PATIENT, DEVICE, AND CONCLUSION CODING HAS BEEN UPDATED IN THIS REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REFERENCES THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8703, LOT# J94142142, IMPLANTED: (B)(6) 1995, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840. LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ALL INFORMATION PREVIOUSLY REPORTED IN MANUFACTURES REPORT # 6000030-2008-02448. NEW INFORMATION INDICATED COMPLAINT ALSO WAS ON PUMP.

    Description of Event or Problem · 1

    FOLLOWING THE PREVIOUSLY REPORTED TIGHTNESS, OVERLOAD OF MEDICATION, AND LOOSE LEGS (LIKE NOODLES) CAUSING THE PATIENT TO NOT BE ABLE TO WALK, THE PHYSICIAN TRIED THE ITB THERAPY AGAIN FOR THE PATIENT AND THE PATIENT HAD PROBLEMS EVEN AT THE LOWEST LEVEL. THE DOSE HAD BEEN VERY HIGH AT FIRST (1,000MCG/DAY) BUT THE PATIENT WAS TOO LOOSE AFTER THE SCAR TISSUE WAS REMOVED. THE PATIENT WAS ON HIS BACK FOR SIX WEEKS AND COULDN'T WALK. THE PHYSICIAN CONTINUED TO LOWER THE DOSE UNTIL IT BECAME THE LOWEST DOSE AVAILABLE (25MCG/DAY) AND THE PATIENT WAS STILL TIGHT. THE DOSE WAS THEN INCREASED BACK TO 500MCG/DAY. A CATHETER DYE STUDY HAD BEEN PERFORMED AT SOME POINT AND WAS NORMAL. THE OVERALL SYMPTOMS WERE DESCRIBED AS HAVING A SUDDEN ONSET. THE PATIENT HAD ALSO STOPPED THERAPY FOR A YEAR AS HIS RECEPTORS WERE OVERLOADED. CURRENTLY THE PATIENT WAS HAVING PAIN IN HIS BACK AND SPINE (SINCE (B)(6) 2015, GRADUAL ONSET). THE PUMP WAS NOT WORKING OR FUNCTIONING LIKE BEFORE AND THE SPINE PHYSICIAN WANTED TO DO AN MRI. IT WAS STATED THAT THE PUMP HAD NOT BEEN DELIVERING MEDICINE FOR A NUMBER OF YEARS (AS PREVIOUSLY REPORTED, MADE THE PATIENT A LOT TIGHTER).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THAT SINCE THE PUMP WAS PUT IN THE PUMP HAS NOT HELPED SYMPTOMS. THE BACLOFEN WAS NO LONGER WORKING AND WAS MAKING THE PATIENT TIGHT. THE PATIENT STATED THAT HE HAD A DYE STUDY DONE AND THE ¿MEDICATION WAS GETTING STUCK¿ IN THE NECK. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL. IT WAS REPORTED IN THE PUMP LOGS THAT ON (B)(6) 2008 THE CATHETER WAS REVISED. A 21CM WAS REMOVED OF THE ORIGINAL 89CM CATHETER AND REPLACED WITH 34CM OF A CATHETER SPINAL SEGMENT REVISION KIT (8596A) LEAVING 103CM IMPLANTED. THE CATHETER WAS LOCATED AT THE T6 VERTEBRAE. NO FURTHER COMPLICATIONS WERE ANTICIPATED/REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133949 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Required Intervention