BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2151678 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-09575
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2010
    Report Date
    June 27, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED THAT A LEAD REVISION WAS PERFORMED AND CONFIRMED THIS LEAD HAD DISLODGED AT AN UNDETERMINED TIME FOLLOWING IMPLANT. DURING THE EXPLANT PROCEDURE THIS LEAD WAS DESTROYED AND DISCARDED. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. 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 PHYSICIAN ELECTED NOT TO PERFORM A REVISION PROCEDURE AT THIS TIME. 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

    THIS ISSUE WAS REPORTED AND ALSO CAPTURED IN REPORT NUMBER: 2124215-2011-12950.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT INFORMATION THE FIELD INDICATES THE THIS RIGHT ATRIAL (RA) LEAD IS LIKELY DISLODGED. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING PAIN IN THE CHEST AND A FLUCTUATION IN BLOOD PRESSURE AND PULSE RATE. THERE WERE NO FURTHER ADVERSE PATIENT EFFECTS REPORTED. THE LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THIS RIGHT ATRIAL (RA) LEAD THAT OCCURRED PRIOR TO AND FOLLOWING THE CONFIRMED DISLODGEMENT. A FINAL SUMMARY WAS PROVIDED AT A LATER DATE, THIS IS THE ADDITIONAL INFORMATION. INFORMATION PROVIDED FROM A PATIENT ADVOCATE, THAT PRIOR TO THE IMPLANT PROCEDURE OF THIS RA LEAD, THE PATIENT ENDURED A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). FOLLOWING THE DEVICE IMPLANT PROCEDURE, THE PATIENT'S ATRIAL FIBRILLATION (AFIB) HAD NOT IMPROVED. DURING A ROUTINE DEVICE CHECK, THIS RIGHT ATRIAL (RA) LEAD ILLUSTRATED NOISE AND OVERSENSING UPON PACING AND SENSING. LEAD INTEGRITY WAS QUESTIONED AT THAT TIME, HOWEVER, WAS NOT VERIFIED, DUE TO THE PATIENT'S ONGOING AFIB CONDITION. THE DEVICE WAS THEN PROGRAMMED TO VVIR 60 BPM, UNTIL THE PHYSICIAN WAS ABLE TO SEE THE PATIENT. APPROXIMATELY ONE MONTH LATER, WITH THE PATIENT CONTINUING TO PRESENT IN AFIB, THE PHYSICIAN ORDERED THE DEVICE TO BE PROGRAMMED TO LOWER THE VENTRICULAR LOWER RATE LIMIT TO 40 BPM. AN X-RAY WAS THEN PERFORMED AND IT WAS DETERMINED THAT THE LEAD HAD DISLODGED, RESULTING IN A LOSS OF PACING AND SENSING. ONCE THE PHYSICIAN DETERMINED THAT THE RA LEAD HAD DISLODGED, THE RA LEAD REPLACEMENT PROCEDURE WAS SCHEDULED. HOWEVER, AS A RESULT OF THE PATIENT ENDURING A PROCEDURE FOR STENT PLACEMENT, THE LEAD REVISION PROCEDURE WAS RESCHEDULED TO A LATER DATE. AN INVASIVE REVISION PROCEDURE WAS THEN PERFORMED AND THE RA LEAD WAS REMOVED WITHOUT ISSUE AND REPLACED. AS PREVIOUSLY REPORTED DURING THE EXPLANT PROCEDURE THIS LEAD WAS DAMAGED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R