BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4173411 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19719
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748925, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 748925, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 399930, LOT # V002603, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 399930, LOT# V002603, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 399930, LOT# V002603, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL NO. (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE BATTERY WAS AT NORMAL END OF LIFE. TELEMETRY AND OUTPUT WERE OKAY. ANALYSIS OF THE EXTENSIONS (SERIAL NO. (B)(4)) FOUND NO SIGNIFICANT ANOMALIES. THE DISTAL END SETSCREWS WERE MISSING. THE # 0 SETSCREWS WERE NOT RETURNED. ANALYSIS OF THE LEAD (LOT NO. V002603) FOUND NO SIGNIFICANT ANOMALY. THE PROXIMAL END/CONDUCTOR WAS BROKEN DUE TO OVERSTRESS/DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCE ISSUE ON NUMBER 3 WITH A ¿???¿ ERROR. THE PATIENT WAS TO HAVE A PREOPERATIVE CONSULT WITH THE HEALTHCARE PROFESSIONAL (HCP) TO DISCUSS POSSIBLE IMPLANTABLE NEUROSTIMULATOR (INS)/LEAD/EXTENSION REPLACEMENT. THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT ON THE DAY PRIOR TO REPORT. THE PATIENT WAS CONCERNED THAT THE INS WAS RUNNING OUT OF ENERGY AND DID NOT WANT TO BE WITHOUT THE INS. AN IMPEDANCE CHECK REVEALED THAT NUMBER 3 CONTACT SHOWED HIGH IMPEDANCE BUT WAS NOT BEING USED IN A BI-POLE CONFIGURATION. THE PATIENT ALSO REPORTED THAT SHE HAD A PAIN AROUND THE INS POCKET FOR ABOUT A WEEK. THE PATIENT REPORTED THAT SHE MADE A FAR STRETCH WITH HER RIGHT HAND TO HER LEFT SIDE AND FELT A PAIN. THE ISSUE HAD NOT RESOLVED, BUT THE PAIN WAS NOT 24/7. THE MANUFACTURING REPRESENTATIVE SHOWED THE PATIENT AND HER HUSBAND THE BATTERY LIFE INDICATOR OF 40-90 PERCENT AND THEY WANTED TO TALK TO THE HCP ABOUT AN INS REPLACEMENT. THE PATIENT WAS HAPPY WITH HER PAIN RELIEF. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE PAIN WAS POSSIBLY THE CONTACT SELECTION. THE DEVICE WAS REPROGRAMMED FOR BETTER COVERAGE, BUT THE PATIENT WAS UNABLE TO GET SATISFACTORY ¿LBP¿ RELIEF. THE REP WAS UNSURE IF IT WAS DEVICE RELATED. AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT WAS SCHEDULED FOR NOVEMBER WITH A POSSIBLE LEAD REPLACEMENT. IT WAS NOTED THAT CONTACTS 0-2 WERE ¿???¿ AND 0-3 WERE GREATER THAN 4,000 OHMS. IT WAS ALSO NOTED THAT 0-4 WERE ¿???¿, 2 AND 3, 3 AND 4, 5, 6, 7 WERE ALL GREATER THAN 4,000 OHMS. THE REPLACEMENT WAS DISCUSSED WITH THE PHYSICIAN¿S ASSISTANT. THE PATIENT AND HER HUSBAND WANTED TO MOVE FORWARD WITH THE REPLACEMENT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL FOLLOW-UP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE EXPLANTED ON (B)(6) 2014. THE EXTENSIONS WERE PARTIALLY REMOVED ON (B)(6) 2014. THE PATIENT'S DEVICE WAS NOT WORKING AND HAD MULTIPLE IMPEDANCE ISSUES UPON INTERROGATION. THE LEAD WAS FOUND TO BE BROKEN UPON EXPLORATION AND WAS REPLACED. IT WAS NOTED THAT SYSTEM MALFUNCTIONS WERE SEEN. THE CONNECTION FROM THE EXTENSION TO THE LEAD BODY, HOUSING CONTACTS 0-3, APPEARED TO BE COMPLETELY EXPOSED OUTSIDE THE "SILASTIC" HOUSING. IT WAS NOTED THE INS HAD NORMAL BATTERY DEPLETION. THE PATIENT WAS NOT IN A CLINICAL STUDY. NO PATIENT DEATH OR INJURY WAS REPORTED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE NEW SYSTEM WAS WORKING WELL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S REPLACEMENT WOULD BE NEXT WEEK. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL FOLLOW-UP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653807 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention