BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1952835 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24393
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    January 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY ONE YEAR LATER, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINIC STATING THAT THE PATIENT HAD BEEN SYNCOPAL DUE TO THE PREVIOUSLY REPORTED LEAD DISLODGEMENT. ADDITIONALLY, THE DEVICE IS A PACEMAKER AND NOT AN ICD AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THIS MEDICAL DEVICE AND ASSOCIATED LEAD REMAIN ACTIVELY IN SERVICE. IN RESPONSE TO THIS ISSUE, THE DEVICE OUTPUTS WERE INCREASED TO 5.0 VOLTS FOR THE TIME BEING. ALSO, A CHEST X-RAY WAS TO BE DONE. THE OUTCOME WAS NOT KNOWN AT THE TIME OF THIS INITIAL REPORT. THE INVESTIGATION REMAINS OPEN AT THIS TIME. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THIS RV LEAD AND THE ASSOCIATED ICD HAVE BEEN REMOVED FROM SERVICE. IT WAS OBSERVED THAT THE RV LEAD HAD DISLODGED RESULTING IN A VERY HIGH THRESHOLD OF 3.2 VOLTS AT 0.5 MS. THE PATIENT WAS NOTED AS BEING PACEMAKER DEPENDENT AND VERY YOUNG. THE PHYSICIAN ELECTED TO IMPLANT AN ENTIRELY NEW RV LEAD AND DEVICE. TO DATE, THESE MEDICAL DEVICES HAVE NOT BEEN RETURNED TO BOSTON SCIENTIFIC. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    THE DESCRIPTION FROM THE INITIAL MEDWATCH REPORT WAS EVALUATED AND MODIFIED BASED ON REVIEW OF INFORMATION THAT HAD BEEN RECEIVED IN 2010 TO ADD CLARITY TO THE EVENT. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS FIELD REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO REPORT THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING POSSIBLE OVERSENSING (CROSSTALK) IN THE RV. THE LOCAL REPRESENTATIVE COMMENTED THAT THIS WAS ASSOCIATED WITH PACING INHIBITION, HOWEVER, THERE WAS A JUNCTIONAL ESCAPE RHYTHM PRESENT WITH A RATE OF 30 BPM. THE RV PACING IMPEDANCE HAD DECREASED FROM 820 OHMS TO 560 OHMS AND NO ELECTROGRAM NOISE WAS IDENTIFIED. RV SENSING IS ADEQUATE, HOWEVER, THE RV PACING THRESHOLDS HAD INCREASED TO 3.5 VOLTS. THE DEVICE'S RV PACING OUTPUT HAD BEEN PROGRAMMED TO 2.5 VOLTS. THE PATIENT WAS SYMPTOMATIC (DIZZINESS) AND THESE ADVERSE EPISODES OCCURRED SEVERAL TIMES A DAY. TS REVIEWED THE ELECTROGRAM PRINTOUTS AND INFORMED THE FIELD REPRESENTATIVE THAT THE CROSSTALK OBSERVATION MAY ACTUALLY REPRESENT LOSS OF CAPTURE OR T-WAVE OVERSENSING. TS WAS INFORMED THAT THE PATIENT HAD BEEN SCHEDULED FOR A CHEST X-RAY AND THE RV PACING OUTPUT HAD BEEN REPROGRAMMED TO 5.0 VOLTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID INHIBIT PACING AS A RESULT OF VENTRICULAR LOSS OF CAPTURE OR POSSIBLY OVERSENSING OF ATRIAL ACTIVITY. THE LOCAL AREA SALES REPRESENTATIVE NOTED THAT THE PACE THRESHOLD WAS AT 3.5 VOLTS AND THAT THE PATIENT HAD BEEN PRESENTED WITH 2.5 VOLTS. AN ESCAPE BEAT WAS PRESENT IN THE 30'S. THE PATIENT HAD EXPERIENCED SOME DIZZY SPELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 273 MO Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)