BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2173185 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10783
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 31, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE AND LEAD REMAIN IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    TO DATE THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT. AT THAT TIME A FINAL REPORT WILL BE SENT AFTER ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEAD HAVE BEEN EXPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP VISIT, THIS PACEMAKER WAS NOTED TO BE IN UNIPOLAR MODE AS A LEAD SAFETY SWITCH HAD OCCURED DUE TO OUT OF RANGE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. IN ADDITION, A HOLTER MONITOR REPORT WAS REVIEWED AND REVEALED HIGH ATRIAL RATES FOLLOWED BY EXTENDED PAUSES WITH NO PACEMAKER STIMULATION. THE PATIENT WAS NOT SYNCOPAL DURING THESE EPISODES, HOWEVER, FELT 'HEAD RUSHES', SHORTNESS OF BREATH, AND PALPITATIONS. DURING DEVICE TESTING, NOISE AND EXTENDED PACING PAUSES OF THREE SECONDS WERE NOTED ON STORED ELECTROGRAMS AND WHEN PRESSURE WAS APPLIED TO THE DEVICE POCKET. A CONNECTION OR HEADER ISSUE WAS SUSPECTED. THE DEVICE WAS REPROGRAMMED FROM A SINGLE CHAMBER INHIBITED RATE RESPONSIVE (SSIR) MODE TO A SINGLE CHAMBER FIXED PACING RATE RESPONSIVE (SOOR) MODE AND THE PACING VOLTAGE WAS INCREASED FROM 2 TO 3V. A CHEST X-RAY WAS PERFORMED AND REVEALED NO EVIDENCE OF HEADER DISPLACEMENT AND THE TIP OF THE LEAD PIN APPEARS TO EXTEND BEYOND THE APPROPRIATE, PROXIMAL ELECTRICAL CONNECTOR BLOCK IN THE HEADER OF THE DEVICE. THEREFORE, THERE WAS NO OBVIOUS EXPLANATION FOR THE MALFUNCTION OF THE PACING SYSTEM. THE PATIENT HAS HAD NO FURTHER SEVERE HEAD RUSHES SINCE THE RECENT DEVICE REPROGRAMMING; HOWEVER, SHE HAS FELT HER HEART BEATING VERY FORCEFULLY DURING THE NIGHT, LIKELY RELATED TO THE HIGHER STIMULATION VOLTAGE THAT WAS PROGRAMMED. THE POTENTIAL NEED FOR REPEAT SURGERY HAS BEEN DISCUSSED WITH THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING A RECENT DEVICE CHANGE OUT ON (B)(4) 2012, THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A SUSPECTED LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TO DATE IT, THE LOCATION OF THE LEAD IS UNKNOWN.

    Description of Event or Problem · 1

    APPROXIMATELY (B)(6) MONTHS LATER, THIS PACEMAKER WAS NOTED TO BE IN UNIPOLAR MODE AS A LEAD SAFETY SWITCH HAD OCCURRED DUE TO OUT OF RANGE IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD GREATER THAN 2500 OHMS. IN ADDITION, A HOLTER MONITOR REPORT WAS REVIEWED AND REVEALED HIGH ATRIAL RATES FOLLOWED BY EXTENDED PAUSES GREATER THAN 7 SECONDS WITH NO PACEMAKER STIMULATION. THE PATIENT WAS NOT SYNCOPAL DURING THESE EPISODES, HOWEVER, FELT DIZZY SPELLS. MOST SYMPTOMS OCCUR WHILE SHE IS DRIVING OR LYING ON HER RIGHT SIDE. A LEAD AND HEADER CONNECTION ISSUE WAS SUSPECTED. A REVISION PROCEDURE WAS PERFORMED, AND THE LEADS WERE DISCONNECTED FROM THE HEADER AND INSERTED INTO A NEW DEVICE. THE LEADS WERE INSERTED INTO A PACING SYSTEM ANALYZER (PSA) AND TESTED AND REVEALED ALL OTHER MEASUREMENTS WERE STABLE AND WITHIN NORMAL RANGE VISUAL INSPECTION OF THE DEVICE REVEALED DAMAGE TO THE OUTSIDE OF THE CAN AS MANIPULATION WAS USED TO REMOVE THE DEVICE. ALSO VISUAL INSPECTION OF THE DEVICE AND LEAD REVEALED NO HEADER OR CONNECTION ISSUE. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED ON DEVICE PROGRAMMING FOR OPTIMIZATION FOR PATIENT. THE DEVICE WAS EXPLANTED AND SENT BACK FOR ANALYSIS. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    CORRECTIVE REPORT SENT DUE TO AN UPDATED EVENT TYPE - TO AE AND PP DEVICE DUE TO SERIOUS INJURY PREVIOUSLY REPORTED

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING A RECENT DEVICE CHANGE OUT ON (B)(6) 2012, THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO A SUSPECTED LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. LEAD WAS SURGICALLY ABANDONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other (B)(4)| (B)(4)