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Model Number 6416 |
Device Problems
Pacing Problem; Device Dislodged or Dislocated
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Event Date 05/01/2003 |
Event Type
Injury
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Manufacturer Narrative
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This information is based entirely on journal literature.
This event occurred outside the us.
All information provided is included in this report.
Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.
Patient information is limited due to confidentiality concerns.
Without a lot number or device serial number, the manufacturing date cannot be determined.
Since no device id was provided, it is unknown if this event has been previously reported.
Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.
Referenced article: ¿utility and safety of prolonged temporary transvenous pacing using an active-fixation lead: comparison with a conventional lead.
¿ pace 2003; 26:1245¿1248.
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Event Description
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A journal article was reviewed that contained information regarding this temporary pacing lead model.
Multiple patients were noted in the article; however, a one to one correlation could not be made with unique serial numbers with the available information provided.
The article indicated that there were patients with infection, venous thrombosis ¿inappropriate sensing,¿ and dislocations.
The status/location of the lead is unknown.
Further follow up did not yet yield any additional information.
No further patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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