BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4628813 · Received March 24, 2015

    Report

    Report Number
    9614453-2015-00549
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    February 26, 2015
    Report Date
    April 29, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR MODEL 37702 SN: (B)(4) FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37081-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. (B)(4). 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: 37081-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. (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

    IT WAS REPORTED THAT AT THE IMPLANT PROCEDURE, SOME OF THE ELECTRODES SHOWED HIGH IMPEDANCES. THE EXTENSION WAS REMOVED, CLEANED, AND RECONNECTED, BUT THE IMPEDANCES REMAINED HIGH. THE EXTENSION WAS REMOVED A THIRD TIME AND CLEANED, BUT THE ISSUE DID NOT RESOLVE. THE DECISION WAS MADE TO ¿LET THE SYSTEM SETTLE¿ BUT THE IMPEDANCES DID NOT RESOLVE OVER THE ENSUING DAYS. THE DEVICE REMAINED IMPLANTED BUT REPLACEMENT WAS BEING CONSIDERED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE FOLLOWING IMPEDANCE VALUES TESTED AT 3 V WITH ELECTRODE 0 SET AS THE REFERENCE (ALL VALUES IN OHMS): 1- 755, 2- 26229, 3- 26229, 4- 26229, 5- >40000, 6- 26229, 7- 818, 8- 507, 9- 779, 10- 852, 11- >40000, 12- >40000, 13- >40000, 14- >40000, AND 15- >40000. THE PATIENT WAS DOING WELL, BUT THE THERAPY WAS ONLY COVERING HALF OF THE AREA IT WAS COVERING DURING THE TRIAL. A REVISION OCCURRED ON (B)(6) 2015 AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. AFTER REPLACEMENT, THE IMPEDANCES WERE WITHIN NORMAL RANGES AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197025 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW IPG MFG SWITZERLAND 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention