BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 7 ELITE

    MDR report key: 8147533 · Received December 10, 2018

    Report

    Report Number
    3006705815-2018-03202
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    November 14, 2018
    Report Date
    February 1, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067020222
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDED DATE OF EXPLANT.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DATE RECEIVED BY MANUFACTURER WAS INADVERTENTLY OMITTED WITHIN FOLLOW-UP NUMBER 1 AND SHOULD HAVE BEEN 20DEC2018. CORRECTED DATA: DATE OF EXPLANT WAS COMPLETED WITHIN FOLLOW-UP REPORT NUMBER 3. THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    CHECKED ADVERSE EVENT AND CHECKED OTHER (SERIOUS). ADDED EXPLANT DATE ((B)(6) 2018). ADDED- MODEL 3662; SCS IPG; ADDED PMA CODE: P010032.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED INDICATED THE PATIENT IS EXPERIENCING PAIN AT THE IPG SITE, HOWEVER NO INTERVENTION IS PLANNED TO ADDRESS THE ISSUE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THEIR ORIGINAL IPG WAS EXPLANTED DUE TO AN INFECTION BEING PRESENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT HAVE SURGICAL INTERVENTION ON (B)(6) 2018 AS PREVIOUSLY REPORTED. THE PATIENT HAS HAD NO SURGICAL INTERVENTION TO DATE.

    Description of Event or Problem · 1

    FOLLOW UP REVEALED SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED DUE TO A SUSPECTED INFECTION AT IPG SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985732 PROCLAIM 7 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3662 A000065851 05415067020222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 3662ANS