BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2951597 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01562
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    August 6, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S171
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCT: 0158 COMPETITOR IMPLANTABLE DEFIBRILLATION LEAD, (B)(6) 2003. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    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: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. CONCOMITANT PRODUCT: 0158 COMPETITOR IMPLANTABLE DEFIBRILLATION LEAD, (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING TWITCHING IN THE POCKET ABOUT 20 PERCENT OF THE DAY WITH POCKET PAIN AND 'JOLTS' OF PAIN THAT WERE INCREASED WITH INCREASING LEFT VENTRICULAR (LV) PACING OUTPUTS AND REDUCED WHEN LV PACING OUTPUT DECREASED. IT WAS ALSO REPORTED THAT THERE WAS AN ALERT FOR THE LV LEAD HAVING IMPEDANCE OF LESS THAN 200 OHMS. A POSSIBLE INSULATION BREACH WAS QUESTIONED. FOLLOW UP WAS SENT TO DETERMINE IF ANYTHING WAS DONE FOR RESOLUTION OF THE PATIENT SYMPTOMS. THE LV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT DUE TO THE PATIENT FEELING A SHOCKING/BURNING PAIN ALL AROUND THE DEVICE THAT THE PHYSICIAN SUSPECTED THERE WAS A BATTERY LEAKAGE FROM THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56451 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD