BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 18297276 · Received December 8, 2023

    Report

    Report Number
    1627487-2023-05862
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    November 16, 2023
    Report Date
    February 6, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05414734406116
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. FURTHER INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: QUATTRODE LEAD, MODEL: 3169, UDI: (B)(4), BATCH: 3615842. COMMON DEVICE NAME: QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), BATCH: 3627362. COMMON DEVICE NAME: QUATTRODE LEAD, MODEL: 3166, UDI:(B)(4), BATCH: 3627362. COMMON DEVICE NAME: QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4), BATCH: 4081179. COMMON DEVICE NAME: QUATTRODE LEAD, MODEL: 3166, UDI: (B)(4) , BATCH: 4046673.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00167. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00170. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00172. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00173. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2024-00174. ADDITIONAL INFORMATION INDICATES ALL OF THE PATIENTS LEADS HAD SHIFTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY, PATIENTS LEADS HAD SHIFTED. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN BOTH OF PATIENTS SYSTEMS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEADS SHIFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980119 QUATTRODE LEAD WIDE SPACED, 90 CM SCS LEAD LGW ABBOTT MEDICAL 3169 3254416 05414734406116

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other SCS EXTENSION (X2).| SCS EXTENSION.| SCS IPG.| SCS IPG.| SCS LEAD (X4).| SCS LEAD.