BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3442919 · Received November 1, 2013

    Report

    Report Number
    3004209178-2013-20039
    Event Type
    Injury
    Date Received
    November 1, 2013
    Report Date
    November 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# VA0B5MX, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA0B5MX, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3389S-40, LOT# VA0B5MX, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA0B5MX, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A POST-OPERATIVE INFECTION AND POSSIBLE CEREBRAL SPINAL FLUID LEAK WAS REPORTED. IT WAS NOTED THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2013 DUE TO THE INFECTION. THERE WAS NO ALLEGED PRODUCT ISSUE. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS, ¿ALIVE - NO INJURY.¿ THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A POST-OPERATIVE INFECTION AT THE BURR HOLE AND AN EXPLANT WAS REQUIRED AS A RESULT OF THE EVENT. IT WAS NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT. IT WAS NOTED THAT THE EXPLANT DATE IN THE ADDITIONAL REPORT CONFLICTED WITH THE ORIGINAL REPORT, AND WAS NOTED AT 2013-(B)(6); IT IS UNCLEAR WHICH DATE IS CORRECT.

    Description of Event or Problem · 1

    IT WAS FURTHER STATED THAT "LAST FEW INFECTIONS HAVE BEEN AT BURR HOLE SITE AS WELL AS POCKET," BUT IT WAS UNKNOWN WHAT EVENT THIS PERTAINED TO. THE INFORMATION WAS ALSO REPORTED IN MANUFACTURER'S REPORTS #3004209178-2013-21565, 3007566237-2013-03854, AND 30042091 78-2013-21568.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD ANTIBIOTICS ADMINISTERED ON (B)(6) 2013. THE PATIENT DID NOT HAVE MENINGITIS. THE PATIENT'S SYMPTOM WAS "DRAINAGE". THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET AND THE LEAD TRACK. A CULTURE WAS OBTAINED FROM THE DEVICE POCKET AND THE CEREBRAL SPINAL FLUID (CSF). THE ORGANISM CULTURE WAS UNKNOWN. THE PATIENT RECEIVED IV ANTIBIOTICS AND HAD A TOTAL DEVICE SYSTEM EXPLANT. IT WAS STATED THAT THE PATIENT OUTCOME WAS "ONGOING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562266 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention