BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2120022 · Received June 8, 2011

    Report

    Report Number
    3004209178-2011-04184
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 15, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTH CARE PROVIDER THAT A PT LOST CONSCIOUSNESS. THE REPORTER STATED THAT THE PT'S HUSBAND SAID HE COULD NOT WAKE HIS WIFE ON (B)(6) 2011. THE NEXT DAY THE PT'S HUSBAND SAID THAT HIS WIFE WAS SITTING UP IN A CHAIR. ON THE DATE OF THE REPORT, THE PT WAS UNRESPONSIVE AND THE REPORTER WANTED THE PUMP STOPPED BUT DID NOT HAVE ACCESS TO A PUMP PROGRAMMER TO FIND OUT THE STATUS OF THE PUMP. THE REPORTER THOUGHT THERE WAS DILAUDID IN THE PUMP BUT WAS NOT SURE. THE REPORTER ALSO DID NOT KNOW IF THERE WAS A RECENT PUMP REFILL. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE REPORTED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N125794011| EXPLANTED: