BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6753602 · Received July 31, 2017

    Report

    Report Number
    3004209178-2017-15873
    Event Type
    Injury
    Date Received
    July 31, 2017
    Report Date
    September 28, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE (B)(4) NO LONGER APPLIES. CONCLUSION CODE 92 APPLIES TO THE PUMP, AND CONCLUSION CODE 22 APPLIES TO THE CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCED THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_CATH SERIAL# UNKNOWN PRODUCT TYPE CATHETER PRODUCT ID 8709 LOT# L82370 IMPLANTED: (B)(6)2000 EXPLANTED: (B)(6)2017 PRODUCT TYPE CATHETER IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS IDENTIFIED DENTS ON THE OUTSIDE SURFACE OF THE PUMP {THAT ARE CONSISTENT WITH EXPLANT DAMAGE}. THE DENTS DID NOT AFFECT THE PERFORMANCE OF THE PUMP IN THE LABORATORY. ANALYSIS OF THE UNKNOWN CATHETER/SC CONNECTOR FOUND CORING, TEARS, CUTS IN SEAL THAT MET LEAK CRITERIA PER NDHF1162-113599. EVAL CODE - CONCLUSION CODE ¿ 11 IS BEING UPDATED TO 71 FOR THIS EVENT REGARDING THE PUMP AND 12 REGARDING THE UNKNOWN CATHETER. RECENT FDA CODING CHANGES OFFER LIMITED OPTIONS FOR MEDICAL DEVICE EVALUATION CONCLUSION CODING. MEDTRONIC SELECTED CONCLUSION CODE 12 BECAUSE, ALTHOUGH THE DEVICE WAS OPERATING WITHIN SPECIFICATIONS, MEDTRONIC MODIFIED THE SPECIFICATIONS MAKING THIS THE CLOSEST CODE AVAILABLE WITH RESPECT TO THIS EVENT. 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: 8709, LOT# L82370, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: CATHETER. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP VIA THE REPRESENTATIVE REPORTED THE REASON FOR THE CATHETER REPLACEMENT WAS DUE TO LOSS OF THERAPY PER THE PHYSICIAN. THE LOSS OF THERAPY HAD BEEN RESOLVED AS THE DEVICES WERE REPLACED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE DRUG INFUSION PUMP INDICATED FOR SPINAL PAIN. THE PUMP CONTAINED AN UNKNOWN BRAND OF MORPHINE WITH AN UNKNOWN CONCENTRATION AND DOSE. IT WAS REPORTED THE PUMP HAD A STALL. THE PATIENT EXPERIENCED A LOSS OF THERAPY. IT WAS UNKNOWN WHAT ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS MIGHT HAVE LED OR CONTRIBUTED TO THE ISSUE. ACTIONS/INTERVENTIONS TAKEN INCLUDED A SYSTEM EXPLANT AND REPLACEMENT ON (B)(6) 2017. IT WAS UNKNOWN IF THE ISSUE HAD BEEN RESOLVED AT THE TIME OF THE REPORT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534641 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention