BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 3170265 · Received June 14, 2013

    Report

    Report Number
    6000153-2013-00118
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    CONCOMITANT PRODUCTS: PRODUCT ID 355531, LOT # N383755, PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD AND STYLET REVEALED NO ANOMALIES. IT WAS STATED IMPEDANCES WERE MEASURED AND ALL READINGS WERE NORMAL.

    Additional Manufacturer Narrative · 1

    (B)(4)

    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 THE HEALTHCARE PROFESSIONAL DOING THE TRIAL LEAD HAD TRIED TO IMPLANT THE LEAD, BUT THE PATIENT FELT STIMULATION ¿FUNNY STRONG.¿ IT WAS NOTED THAT WHEN THE LEAD WAS CONNECTED TO THE EXTERNAL NEUROSTIMULATOR THE IMPEDANCES WERE OUT OF RANGE AND THE LEAD WAS REPLACED WITH A NEW TRIAL LEAD. IT WAS FURTHER NOTED THE PATIENT HAD RECOVERED WITHOUT SEQUELA FOLLOWING REMOVAL OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING THE 3874-45 LEAD WITH THE MULTI-LEAD TRIALING CABLE , IMPEDANCES WERE OUT OF RANGE AND THE PATIENT WAS UNABLE TO SENSE PARESTHESIA. IT WAS NOTED THAT THE MULTI-LEAD TRIALING CABLE WAS REPLACED WITH A NEW ONE AND ALL IMPEDANCES WERE WITHIN NORMAL LIMITS BUT THE PATIENT WAS STILL UNABLE TO SENSE PARESTHESIA WITH THIS LEAD. THE PATIENT WAS REPORTEDLY ABLE TO FEEL PARESTHESIA WITH THE SECOND 3874-45 LEAD BUT NEEDED BILATERAL COVERAGE. THE NON-FUNCTIONING LEAD WAS REMOVED AND REPLACED WITH A NEW ONE; BOTH LEADS WERE THEN CONNECTED TO THE MULTI-LEAD TRIALING CABLE AND THE PATIENT SENSED PARESTHESIA. IT WAS ADDITIONALLY NOTED THAT TWO 3874-45 LEADS WERE IMPLANTED AND CONNECTED TO THE MULTI-LEAD TRIALING CABLE. IMPEDANCES WERE REPORTEDLY OUT OF RANGE WITH ONE LEAD IN CHANNEL 0-7. THEY REPORTEDLY SWITCHED TO 8-15 AND IT WAS NOT OUT OF RANGE. AFTER CHANGING THE MULTI-LEAD TRIALING CABLE THE SAME LEAD SHOWED OUT OF RANGE IMPEDANCES BUT THAT TIME ON EITHER CHANNEL. IT WAS NOTED THAT THE OTHER LEAD WAS WITHIN NORMAL LIMITS IN EITHER CHANNEL. THE ASSUMPTION WAS MADE THAT THE LEAD WAS DEFECTIVE AND IT WAS REPLACED WITH ANOTHER LEAD. IMPEDANCES WERE THEN NORMAL AND THE PATIENT¿S PAIN WAS COVERED BY PARESTHESIA. BOTH THE LEAD AND THE MULTI-LEAD TRIALING CABLE WERE NOTED AS DEFECTIVE AND MALFUNCTIONING. IT WAS ALSO REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND NEVER HAD THERAPEUTIC EFFECT. THE PATIENT REPORTEDLY HAD LOW BACK PAIN AND LEFT LEG TO FOOT PAIN. IT WAS NOTED THAT THE LEAD WAS NEVER IMPLANTED AND THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS 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
    270840 N/A STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW NEURO - VILLALBA 387445 VA08FPB

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR