BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE STIMULATOR

    MDR report key: 2871805 · Received December 13, 2012

    Report

    Report Number
    3007566237-2012-03003
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-39. PRODUCT TYPE: ACCESSORY. UPDATED PMA / 510(K) #. ANALYSIS OF THE LEAD FOUND THAT THE CONDUCTOR BODY WAS BROKEN AT THE TITAN ANCHOR SITE. IT WAS STATED 7 CONDUCTORS WERE BROKEN 25.5 CM FROM THE DISTAL END. THERE WERE TITAN ANCHOR IMPRESSIONS IN THE OUTER INSULATION 26.2 TO 27.2 CM FOR THE DISTAL END. CIRCUITS 0, 3, AND 4 WERE OPEN. CIRCUITS 1, 2, 6, AND 7 WERE INTERMITTENT. CIRCUIT 5 TESTED AT 5.4 OHMS. THERE WERE NO SHORTS BETWEEN CIRCUITS (DRY). ANALYSIS OF THE TITAN ANCHOR FOUND NO SIGNIFICANT ANOMALY. IT WAS STATED THE SILICONE OF THE ANCHOR WAS CUT.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3877-45, LOT # 0204731924, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NOT FEELING PARESTHESIA. HIGH IMPEDANCES WERE MEASURED. IT WAS ALSO NOTED THE LEAD HAD BEEN USED FOR TWO MONTHS. THERE WAS NO HARM OR INJURY TO THE PATIENT. REPLACEMENT OF THE ELECTRODE WAS REQUIRED FOR RESULT OF THE EVENT. PATIENT WAS FEELING PARESTHESIA AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED "NOTHING STRANGE" WAS OBSERVED ON THE FLUOROSCOPY. IT WAS STATED THE LEAD WAS PROGRAMMED AS FOLLOWS: +4, 5-, 6+, AT 390MHZ, 20US. THE AMPLITUDE WAS SET AT 3.8V. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention