BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2950132 · Received February 8, 2013

    Report

    Report Number
    3007566237-2013-00421
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LOT #0203963998) FOUND THAT SOME CONDUCTORS WERE BROKEN AT THE ANCHOR SITE. TWO CONDUCTORS WERE BROKEN WERE 23.5 CM FROM THE DISTAL END. A FUNCTIONAL TEST FOUND THAT CIRCUIT #0 WAS OPEN, #1 AS 100.9 OHMS, #2 WAS OPEN, #3 WAS 94.0 OHMS. THERE WERE NO SHORTS BETWEEN CIRCUITS. ANALYSIS OF THE EXTENSION FOUND THAT THE BODY HAD BEEN SEGMENTED. A FUNCTIONAL TEST OF THE SEGMENT RETURNED FOUND THAT THE CONTINUITY WAS ACCEPTABLE ON ALL CIRCUITS AND THERE WERE NO SHORTS BETWEEN CIRCUITS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A-45, LOT# 0203963998, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. 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

    ANALYSIS OF THE LEAD (LOT #0203963998) FOUND THAT SOME CONDUCTORS WERE BROKEN AT THE ANCHOR SITE. TWO CONDUCTORS WERE BROKEN WERE 23.5 CM FROM THE DISTAL END. A FUNCTIONAL TEST FOUND THAT CIRCUIT #0 WAS OPEN, #1 AS 100.9 OHMS, #2 WAS OPEN, #3 WAS 94.0 OHMS. THERE WERE NO SHORTS BETWEEN CIRCUITS. ANALYSIS OF THE EXTENSION FOUND THAT THE BODY HAD BEEN SEGMENTED. A FUNCTIONAL TEST OF THE SEGMENT RETURNED FOUND THAT THE CONTINUITY WAS ACCEPTABLE ON ALL CIRCUITS AND THERE WERE NO SHORTS BETWEEN CIRCUITS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD 'GOOD PARESTHESIA COVERAGE AND PAIN RELIEF' AFTER THE LEAD WAS REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LOSS OF PARESTHESIAS. THE REPORTER STATED THAT TELEMETRY WAS DONE AND THE DEVICE WAS INTERROGATED BY A NURSE ON (B)(6) 2012 AND ALL IMPEDANCES WERE HIGH. THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED. IT WAS NOTED THAT THE PATIENT HAD A RETURN OF PAIN. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53656 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention