Model Number 439888 |
Device Problems
Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Migration (4003)
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Patient Problems
Erosion (1750); No Code Available (3191)
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Event Date 07/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: 6935m55 lead, implanted (b)(6) 2017; dtba1qq device, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the implanted leads migrated and/or clustered in the device pocket with a lead segment beginning to protrude under the skin.The cardiac resynchronization therapy defibrillator (crt-d) system was extracted and a temporary pacing lead was implanted until a system replacement could be performed.The system was later replaced.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the proximal portion of the lead was returned, analyzed, and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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