BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4889156 · Received July 2, 2015

    Report

    Report Number
    3004209178-2015-12725
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    June 9, 2015
    Report Date
    June 9, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V014246, IMPLANTED:(B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 64002, LOT# N318565, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3387S-40, LOT# V014246, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED:(B)(6) 2007, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED:(B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_BURRHOLECAP, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_BURRHOLERING, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-29, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3387S-40, LOT# V014246, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_STIMLOC_ACC, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF ONE OF THE LEADS WITH LOT V014246 REVEALED THE OUTER INSULATION WAS BREACHED 33 CENTIMETERS FROM THE DISTAL END. ANALYSIS OF THE OTHER LEAD WITH LOT V014246 REVEALED NO SIGNIFICANT ANOMALIES. THE LEAD BODY WAS CUT THROUGH AND SEGMENTED. FINAL ANALYSIS OF EXTENSION (B)(4) REVEALED NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY THE EVENT WAS NOTED AS A MALFUNCTION. SUPPLEMENTAL HAS BEEN SENT TO UPDATE TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE WAS UPDATED FOR THE LEAD (LOT # V014246). IT IS NOTED FDC IS STILL APPLICABLE TO THE EXTENSION ((B)(4)) AND THE LEAD (LOT # V014246).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL OF A CLINICAL STUDY INDICATING DIAGNOSTICS INCLUDED TESTS PERFORMED INCLUDED COMPUTERIZED AXIAL TOMOGRAPHY (CAT) SCAN WITH RESULTS INDICATING SOFT TISSUE SWELLING RIGHT FRONTAL PANETAL SCALE, X-RAY WITH NORMAL RESULTS FOR THE SKULL AND CHEST. OTHER DIAGNOSTIC INDICATED MEAN PLATELET VOLUME WAS 8.9, ACOROBIC CULTURE = LIGHT GROWTH STAPH AVEUS, LIGHT GROWTH STAPH EPIDERMIS. INTERVENTIONS INCLUDED PERMANENT DISCONTINUATION OF STIMULATION. MEDICAL THERAPY ALSO INCLUDED CEFAZOLIN 2000 MG THREE TIMES A DAY VIA A PICC LINE. THE PICC LINE WAS REMOVED ON (B)(6) 2015. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION WAS RECEIVED WHICH UPDATED PROTRUSION OF EXTENSION DUE TO LEAD EXPLANTED TO SKIN EROSION AND ETIOLOGY TO SKIN EROSION LEAD/EXTENSION TRACT. DIAGNSOTIC METHODS WERE UPDATED FROM HEPATIC ALKALINE PHOSPHATASE WAS RAISED, CALCIUM, MAGNESIUM, OSMOBILITY, PHOSPHATE PATHOGEN RECOGNITION RECEPTORS WAS SLIGHTLY LOWER, URINALYSIS KETONES TO NO DIAGNOSTIC TESTS PERFORMED, EMERGENCY ROOM VISIT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAD, EXTENSION AND NEUROSTIMULATOR WERE EXPLANTED ON (B)(6) 2015. THERE WAS NO CHANGE TO DIAGNOSTIC TESTS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS PROTRUSION OF THE RIGHT EXTENSION ON THE HEAD NEAR THE EAR DUE TO LEAD EXPLANT. THE RIGHT LEAD WAS EXPLANTED AND DETACHED FROM THE EXTENSION LEFT AT THE TIME OF LEAD EXPLANT. UPON INSPECTION IN THE EMERGENCY ROOM INFLAMMATION AND INFECTION WAS NOTED FOR THE EXTENSION. THE TYPE OF INFECTION WAS UNKNOWN. THE EVENT REQUIRED A HOSPITAL EMERGENCY ROOM VISIT WHICH RESULTED IN ADMISSION. A CAT SCAN WAS PERFORMED AND SWELLING OVER THE EXTENSIONS WAS NOTED. THE ENTIRE SYSTEM WAS EXPLANTED AS AN INTERVENTION. THE EVENT WAS RECOVERED WITH SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROFESSIONAL OF A CLINICAL STUDY REPORTED THERE WAS AN INFECTION AT THE EXTENSION TRACT AND WOUND DEHISCENCE. CAT SCAN RESULTS REVEALED SOFT TISSUE SWELLING IN THE RIGHT FRONTOPARIETAL SCALP. THE CHEM 7 REVEALED ABNORMAL RESULTS FOR GLUCOSE, COMPLETE BLOOD COUNT/RED BLOOD COUNT, HEMOGLOBIN, HEMATOCRIT, MEAN CORPUSCULAR VOLUME, MEAN CELL HEMOGLOBIN, AND MEAN PLATELET VOLUME. FUNGAL AND ACID FAST BACILLI CULTURE WAS NEGATIVE, AEROBIC CULTURE SHOWED LIGHT GROWTH OF STAPH AUREUS AND LIGHT GROWTH OF STAPH EPIDERMIDIS. HEPATIC ALKALINE PHOSPHATASE WAS RAISED, CALCIUM, MAGNESIUM, OSMOBILITY, PHOSPHATE PATHOGEN RECOGNITION RECEPTORS WAS SLIGHTLY LOWER, URINALYSIS KETONES. THE SYSTEM WAS EXPLANTED AND DEBRIDEMENT WAS DONE. VANCOMYCIN, CEFEPIME, AND CEFAZOLIN WERE ADMINISTERED. THE EVENT WAS STILL CONSIDERED RECOVERED WITH SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433055 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R