BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3211333 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07648
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Report Date
    March 23, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CHANGES IN PROGRAMMING WERE ALSO DISCUSSED. CURRENTLY, THE DEVICE AND LEADS REMAIN IMPLANTED AND IN SERVICE. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    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 RA LEAD WERE NOT RETURNED FOR ANALYSIS. THE RV LEAD WAS RETURNED AND ANALYSIS CONFIRMED INSULATION ABRASION AND FOUND EVIDENCE OF UNDER-INSERTION OF THE TERMINAL PIN. LABORATORY ANALYSIS CONCLUDED THE OBSERVED NOISE AND OVERSENSING WAS LIKELY A RESULT OF THE IDENTIFIED INSULATION ABRASION AND MAY HAVE BEEN CONTRIBUTED TO BY UNDER-INSERTION OF THE LEAD IN THE HEADER OF THE DEVICE. 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

    SUBSEQUENTLY, THE PATIENT RETURNED FOR FURTHER EVALUATION AT WHICH TIME ANOTHER EPISODE EXHIBITING NOISE WITH PACING INHIBITION WAS OBSERVED. AN X-RAY WAS TAKEN AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR EVALUATION. A TS CONSULTANT DISCUSSED THAT THE X-RAY SHOWS THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED WHICH WOULD ACCOUNT FOR THE OVERSENSING OBSERVED ON THIS LEAD. IN ADDITION, IT WAS NOTED THAT THE DISTAL COIL OF THE RV LEAD IS PARALLEL TO THE DIAPHRAGM MUSCLE, WHICH WOULD ALSO RESULT IN MYOPOTENTIAL OVERSENSING ON THE RV LEAD. THE TS CONSULTANT DISCUSSED TROUBLESHOOTING METHODS TO HAVE THE PATIENT PERFORM TO DETERMINE THE OVERSENSING WAS DUE NORMAL MYOPOTENTIALS FROM THE DIAPHRAGM OR IF THERE IS A POSSIBLE RV LEAD INSULATION ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH NOISE ON THE PACE/SENSE AND SHOCK CHANNELS THAT RESULTED IN OVERSENSING AND THE DELIVERY OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). IN ADDITION, THE OVERSENSING ALSO LED TO ASYSTOLE FOR MORE THAN TWO SECONDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS REPROGRAMMED TO LENGTHEN THE INITIAL THERAPY DURATIONS AND THE PATIENT WILL BE SEEN AGAIN IN ONE MONTH. A MEMORY DOWNLOAD WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR EVALUATION. THE DATA WAS REVIEWED AND REVEALED THAT THE NOISE WAS CONFIRMED TO BE ON ALL THREE CHANNELS AT THE SAME TIME AND HAD A SIMILAR PATTERN AND FREQUENCY. IT WAS ALSO CONFIRMED THAT THE NOISE OVERSENSING DID RESULT IN ASYSTOLE FOR MORE THAN TWO SECONDS AND THE DELIVERY OF ANTI-TACHYCARDIA PACING (ATP); HOWEVER, NO SHOCKS WERE DELIVERED. THE FIELD REPRESENTATIVE REPORTED THAT THE NOISE COULD BE REPRODUCED ON ALL THREE CHANNELS BY THE PATIENT PRESSING THEIR HANDS TOGETHER BUT THE NOISE WAS NOT STRONG ENOUGH TO BE OVERSENSED AND INHIBIT PACING. THE TS CONSULTANT DISCUSSED THAT THE NOISE COULD EITHER BE DUE POSSIBLE CLAVICULAR CRUSH ON ALL THREE LEADS OR FROM ELECTROMAGNETIC INTERFERENCE (EMI). THE TS CONSULTANT DISCUSSED TROUBLESHOOTING METHODS THAT COULD BE PERFORMED TO HELP DETERMINE THE SOURCE OF THE NOISE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT AT A LATER DATE, THE PATIENT WAS SEEN AGAIN FOR ADDITIONAL TESTING. THE OVERSENSING WAS ONLY ABLE TO BE REPRODUCED WHEN THE PATIENT PRESSED HIS HANDS TOGETHER. THE PHYSICIAN DECIDED TO CHANGE THE SENSITIVITY FROM 0.6 TO 1.0 MVOLTS AND THE OVERSENSING WAS UNABLE TO BE REPRODUCED AGAIN. THE PATIENT IS FEELING BETTER AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEADS AND DEVICE REMAIN IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION ABOUT THIS PATIENT AND ICD SYSTEM. APPROXIMATELY FIVE YEARS LATER, THERE WERE 10 NEW NONSUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES. TWO EPISODES HAD ELECTROGRAMS AVAILABLE FOR REVIEW. THESE SHOWED NOISE SIGNALS BETWEEN 0.5-1.0 MV THAT WERE OVERSENSED AND INHIBITED RV PACING; HOWEVER, THE ASYSTOLE OBSERVED WAS LESS THAN ONE SECOND AND THE PATIENT WAS ASYMPTOMATIC. THE SENSITIVITY SETTING WAS ADJUSTED TO 1.0 MV AND THIS RESOLVED THE OVERSENSING. THE PATIENT WAS HOSPITALIZED AND A LEAD REVISION WAS PLANNED FOR LATER IN THE WEEK. DURING THE PROCEDURE TO REPLACE THE RV LEAD, INSULATION DAMAGE WAS OBSERVED ON THE RA LEAD. THEREFORE, BOTH RA AND RV LEADS WERE EXPLANTED AND THE PATIENT RECEIVED NEW RV LEAD AND A NEW CRT-D. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311759 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R H230| MISMATCH| H190| 0185| 4096