Model Number 6947M62 |
Device Problems
High impedance (1291); Device Contamination with Body Fluid (2317)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/23/2015 |
Event Type
Injury
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Event Description
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It was reported that the patient was admitted to the hospital to interrogate the right ventricular (rv) lead and it was noted the rv lead exhibited high impedance.In addition, during the revision procedure, blood was observed between the silicone coating of the lead.The rv lead was explanted and replaced.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).
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Manufacturer Narrative
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Product event summary: the full lead was returned and analysis indicated the inner insulation of the lead was extrinsically breached due to a cut.It was noted the overlay tubing of the lead was extrinsically breached due to a cut at 23cm.The analyst commented the cut may have occurred during implant.It was also noted there was blood on a defibrillation conductor and it was not obstructed.The analyst commented there was a small amount of body fluid visible in the conductor and that the helix was slightly bent but still operated within specifications.Visual summary analysis of the lead indicated damage at implant.
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Search Alerts/Recalls
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