BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSIA DR

    MDR report key: 1992562 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00328
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BATTERY THAT SHOULD HAVE BEEN REJECTED DURING MANUFACTURING WAS BUILT INTO A DEVICE AND RELEASED. A PRODUCT HOLD ORDER WAS ISSUED, THE DEVICE WAS LOCATED AND SEGREGATED IN DISTRIBUTION. NO PATIENT INVOLVEMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BATTERY THAT SHOULD HAVE BEEN REJECTED DURING MANUFACTURING WAS BUILT INTO A DEVICE AND RELEASED. A PRODUCT HOLD ORDER WAS ISSUED, THE DEVICE WAS LOCATED AND SEGREGATED IN DISTRIBUTION. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSIA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. SEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other