BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 2863712 · Received December 10, 2012

    Report

    Report Number
    6000032-2012-00215
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7438, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # L80497, IMPLANTED: (B)(6) 2000, PRODUCT TYPE LEAD; PRODUCT ID *UNKEXT, SERIAL # (B)(4), IMPLANTED: (B)(4) 2000, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATED THAT DEVICE ANALYSIS HAS ALREADY BEEN REPORTED IN THE RELATED MANUFACTURER REPORT # 6000032-2013-00093. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD "BROKE," CAUSING "INTERMITTENT" PULSE TO THE THALAMUS WHICH WAS DESCRIBED AS A "JOLT." IT WAS STATED THAT THE HEALTH CARE PROVIDER (HCP) "WENT IN TO REVISE THE LEAD BUT IT CAUSED A SUBDURAL HEMATOMA." THE HCP REPORTEDLY DECIDED TO LEAVE THE IMPLANT "ALONE" AND JUST TURN IT OFF. IT WAS NOTED THAT THE DEVICE HAD BEEN TURNED OFF FOR THE LAST 10 YEARS. THE PATIENT STATUS WAS UNKNOWN. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE HEALTH CARE PROVIDER REPORTED THE PATIENT HAD NO INFORMATION BECAUSE THE DEVICE HAD NOT BEEN USED OR INTERROGATED "SINCE." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) WAS "INEFFECTIVE" FOR THE PATIENT. IT WAS STATED THAT THE HCP HAD NO "EXPERIENCE" WITH THE PATIENT AND THAT HE DID NOT IMPLANT THE SYSTEM. THE PATIENT WANTED THE SYSTEM REMOVED SO THAT HE COULD HAVE AN MRI. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HIS DEVICE OR THERAPY BUT WAS WORKING WITH HIS DOCTOR. AN APPOINTMENT WAS SCHEDULED FOR (B)(6)-2013. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE WIRE BREAK /COMING LOOSE HAPPENED TWO YEARS AFTER THE IMPLANT. THE DEVICE WAS EXPLANTED ONE DAY PRIOR TO THE REPORT, SEE MANUFACTURER'S REPORT # 6000032-2013-00093.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7424

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention