BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3781693 · Received April 30, 2014

    Report

    Report Number
    6000153-2014-00083
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 6, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-1190-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387-40, LOT# 0207908669, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU _LEADCAP_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_LEADCAP_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD CAP FOUND NO ANOMALY. THERE WAS SIGNIFICANT AMOUNT OF FOREIGN MATERIAL IN THE CONNECTOR BLOCK AND SETSCREW CONSISTENT WITH DRIED BLOOD THAT MADE THE SETSCREW DIFFICULT TO TURN. HOWEVER, AFTER SOAKING THE LEAD CAP AND REMOVING THE FOREIGN MATERIAL, THE SETSCREW TURNED FREELY. A KNOWN GOOD LEAD WAS INSERTED AND THE SETSCREW TIGHTENED WITH A KNOWN GOOD BLUE TORQUE WRENCH. THE SETSCREW TIGHTENED PROPERLY AND HELD THE LEAD IN PLACE. THERE WAS FAINT EVIDENCE IN THE AREA BETWEEN THE SEALING RINGS THAT A BOOT HAD BEEN SUTURED OVER THE LEAD CAP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STAGE ONE SURGERY WAS PERFORMED ON (B)(6) 2014 WHERE THE LEAD CAPS AND THE ¿BLUE TORQUE WRENCH¿ WERE USED TO CAP THE END OF THE LEAD. THE STAGE 2 SURGERY WAS PERFORMED TEN DAYS LATER. DURING THAT SURGERY, THE SURGEON PALPATED THE LEADS CAPS AND MADE AN INCISION ON THE SCALP. THE LEAD CAPS WERE REPORTEDLY ¿BROUGHT OUT¿ FROM UNDERNEATH THE SCALP WITH ¿MINIMAL FORCE¿. BOTH CAPS WERE NOT COVERING THE PROXIMAL ELECTRODE (ELECTRODE 0 LEFT BRAIN AND ELECTRODE 8 RIGHT BRAIN). THE ¿RIGHT BRAIN CONTACTS¿ ON THE RIGHT BRAIN LEAD WERE ALSO NO LONGER EQUIDISTANT. THE SURGEON WAS ABLE TO ALIGN CONTACTS 9, 10 AND 11 INTO THE EXTENSION BUT WAS UNABLE TO CONNECT CONTACT 8. IMPEDANCE TESTING THROUGH THE LEAD SHOWED ELECTRODE 8 WAS OUT OF RANGE ["<(><<)> 10,000" OHMS] AND CONTACTS 9 AND 10 HAD ¿A VERY LOW IMPEDANCE¿ IN BIPOLAR MODE. ALL OTHER IMPEDANCE READINGS WERE NORMAL. THE NEUROLOGIST AIMED TO PROVIDE THERAPEUTIC BENEFIT USING THE REMAINING CONNECTIONS. THERE WAS NO PATIENT INJURY. THE REPORTER WANTED CONFIRMATION THAT WHEN TIGHTENED VIA A TORQUE WRENCH, THE LEAD CAPS MAINTAIN AN ADEQUATE HOLD ON THE LEAD. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS SWITCHED ON THE DAY PRIOR TO THE REPORT. THE REPORTER HADN¿T BEEN CONTACTED WITH ANY ISSUES. INFORMATION IS ALSO REPORTED ON PATIENT'S OTHER LEAD IN MANUFACTURER'S REPORT # 6000153-2014-00082.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259598 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387-40 0207908593

    Patients

    Seq Age Sex Outcome Treatment
    1