BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2062842 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02143
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT SURGERY MACROSTIMULATION WITH ALLIGATOR CLIPS, THE 2 CONTACTS SHOWED IMPEDANCE READINGS OF LESS THAN 50 OHMS. THE PHYSICIAN GROUNDED THE RED CLIP TO THE CANNULA FOR MONOPOLAR STIMULATION. THE LEAD WAS REPLACED AFTER THE PHYSICIAN DETERMINED THAT THE ELECTRODE WAS DEFECTIVE. THE PATIENT DID NOT EXPERIENCE ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female EXPLANTED:| EXTENSION: MODEL 37085, LOT# NKN014292V| EXTENTION: MODEL 37085, LOT# NKN014290V| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: | LEAD: MODEL 3387S, LOT# V296975| LEAD: MODEL 3387S, LOT# V383702| LEAD: MODEL 3387S, LOT# V419196| IMPLANTED:| LEAD: MODEL 3387S, LOT# V419196| LEAD: MODEL 3387S, LOT# V296975| IMPLANTED:| EXTENSION: MODEL 37085, LOT# NKN014292V| IMPLANTED:| EXTENTION: MODEL 37085, LOT# NKN014290V| LEAD: MODEL 3387S, LOT# V383702| IMPLANTED:| IMPLANTED:| EXPLANTED: