BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2811582 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15873
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS ATTEMPTED TO BE INTERROGATED AND THE PATIENT EXPERIENCED ASYSTOLE. THE PROGRAMMING HEAD WAS REMOVED AND PACING RESUMED INTERMITTENTLY. PHYSICIAN REQUESTED THAT THE DEVICE NOT BE INTERROGATED AGAIN WHILE STILL IMPLANTED. PARTIAL INTERROGATION REVEALED THE DEVICE WAS AT ERI. PATIENT WAS PLACED ON EXTERNAL PACING AND LIFE FLIGHTED TO HOSPITAL FOR CHANGEOUT. IT WAS FURTHER REPORTED THAT WHILE DOING A FINAL CHECK, THE PATIENT AGAIN EXPERIENCED AN ASYSTOLIC EVENT. EXTERNAL PACING WAS RESUMED. RE- TESTING OF THE LEAD WAS DONE. NO OVERSENSING NOTED WITH POCKET MANIPULATION. THE LEAD WAS INSPECTED WITH FLUOROSCOPY, NO APPARENT FRACTURES WERE SEEN. PHYSICIAN ASSUMED A POSSIBLE OUTER COIL FRACTURE AND REPROGRAMMED TO UNIPOLAR PACE/SENSE CONFIGURATION. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5054

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD