BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1013654 · Received March 14, 2008

    Report

    Report Number
    6000034-2008-00100
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 23, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED (B)(6) 2010. PATIENT MAY BE REIMPLATED IN SIX TO TWELVE MONTHS.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A "SCAB/POSSIBLE SKIN OPENING" OVER THE COCHLEAR IMPLANT SITE IN 2007. IT WAS RECOMMENDED THAT THE PATIENT DISCONTINUE WEARING THE SOUND PROCESSOR UNTIL HE COULD SEEK MEDICAL TREATMENT. IN TWO MONTHS LATER (DATE NOT REPORTED) THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS FOR TWO WEEKS. THE SURGEON ALSO NOTED THAT THE BED FOR THE IMPLANT WAS NOT DEEP ENOUGH WHICH MAY BE CAUSING THE PATIENT'S SKIN TO BE IRRITATED. ON THE PATIENT WAS SEEN BY HIS PERSONAL CARE PHYSICIAN, WHO "DRAINED PUS" FROM THE SITE AND TREATED THE PATIENT WITH ORAL ANTIBIOTICS. ON SIX DAYS PRIOR TO ORIGINAL DATE, THE PATIENT'S SKIN FLAP REPORTEDLY "LOOKED PRETTY GOOD" AND ORAL ANTIBIOTICS WERE ADMINISTERED FOR FOURTEEN DAYS. THE PATIENT UNDERWENT SKIN FLAP REVISION ON ORIGINAL DATE.

    Description of Event or Problem · 1

    (B)(6) IS A RECOVERING BREAST CANCER PT WHO HAD A PORTACATH INSERTED AT AN EARLIER TIME AT ANOTHER FACILITY. ON (B)(6)2010, THE PHYSICIAN TRIED TO REMOVE IT; HE WAS ABLE TO REMOVE THE PORT, BUT WAS UNABLE TO APPLY SUFFICIENT MANUAL TRACTION TO MOVE OR REMOVE THE CATHETER UNDER LOCAL ANESTHESIA. HER WOUND WAS IRRIGATED, AND CLOSED, WITH CXR SHOWING THAT THE CATHETER REMAINED IN THE SVC. SHE WAS HAVING CHEST DISCOMFORT DURING THE PROCEDURE AND A POST-OP EKG WAS FOUND TO BE NORMAL. ON (B)(6), SHE WAS TAKEN TO INTERVENTIONAL RADIOLOGY AND THE CATHETER WAS REMOVED INTACT VIA DISSECTION. BOTH PROCEDURES WERE WELL TOLERATED AND THE PT WAS DISCHARGED. DOSE OR AMOUNT: NA. DATES OF USE: UNK. DIAGNOSIS OR REASON FOR USE: BREAST CANCER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24R (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention