BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 4875980 · Received June 29, 2015

    Report

    Report Number
    3004209178-2015-12433
    Event Type
    Injury
    Date Received
    June 29, 2015
    Date of Event
    June 4, 2015
    Report Date
    March 1, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6) ; PRODUCT TYPE EXTENSION PRODUCT ID 3487A-45, LOT# V388256, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-45, LOT# V210171, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3487A-56, LOT# V438302, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-45, LOT# V409768, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3487A-56, LOT# J0519366V, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3487A-56, LOT# V003948, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377775, LOT# V003642, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 97714, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 97714, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A POSSIBLE INFECTION. THE PATIENT HAD REDNESS TO THE MEDIAL ASPECT OF THE RIGHT ABDOMINAL INCISION OVER THE STIMULATOR. THE PATIENT WAS GIVEN A TOPICAL ANTIBIOTIC TO APPLY TO THE INCISION SITE. THE EVENT WAS ONGOING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTH CARE PROVIDER (HCP) OF THE CLINICAL STUDY REPORTED THERE WAS NOT DEFINITE DIAGNOSIS OF INFECTION SINCE IT RESOLVED WITH TOPICAL ANTIBIOTIC CREAM. NO DIAGNOSTICS WERE DONE EXCEPT EXAMINATION OF THE AREA. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL OF THE CLINICAL STUDY. A CLINICAL DIAGNOSIS OF POSSIBLE INFECTION OF THE INCISION OVER THE INS WAS REPORTED. THE DEVICE DIAGNOSIS WAS NOT APPLICABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE DIAGNOSTIC METHODS INCLUDED EXAMINATION WHICH SHOWED REDNESS TO THE ABDOMINAL INCISION OVER THE IMPLANTABLE NEUROSTIMULATOR (INS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419305 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Required Intervention