BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 8130119 · Received December 4, 2018

    Report

    Report Number
    1627487-2018-12572
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    November 7, 2018
    Report Date
    January 8, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE ASSOCIATED MDR 1627487-2018-12570.

    Additional Manufacturer Narrative · 1

    CORRECTED TO REFLECT ACCURATE MDR REFERENCES AND CLARIFICATION OF REPORTED EVENT. CORRECTED TO SCS LEAD. MODEL 3186: SCS LEAD. CORRECTED THE INITIAL REPORTER TO THE PHYSICIAN/SURGERY. PHYSICIAN. PMA/520(K): P010032. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THEIR ORIGINAL IPG WAS REPLACED AND ADDITIONAL LEADS WERE IMPLANTED. REPORTEDLY, EFFECTIVE THERAPY WAS OBTAINED AFTER SURGERY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT#1627487-2018-12570. IT WAS REPORTED DURING IPG REPLACEMENT SURGERY ON (B)(6) 2018, (REFERENCE MFR. REPORT#1627487-2018-12578) THE PHYSICIAN WAS UNABLE TO CONNECT THE EXISTING LEADS TO THE IPG DUE TO HIGH IMPEDANCE VALUES ON ALL CONTACTS. AS A RESULT, TWO ADDITIONAL LEADS WERE IMPLANTED IN PLACE OF THE EXISTING LEADS. REPORTEDLY, IMPEDANCE VALUES RETURNED TO NORMAL LIMITS AFTER THE PROCEDURE THUS RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970110 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3504611

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other 3186