Model Number 4674 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that physician stated that the left ventricular (lv) lead was bad.Boston scientific technical services (ts) discussed patient should have a conversation with device physician to discuss concerns and get options.To date, the lead remains in service.No adverse patient effects were reported.
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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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Event Description
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It was reported that physician stated that the left ventricular (lv) lead was bad.Boston scientific technical services (ts) discussed patient should have a conversation with device physician to discuss concerns and get options.To date, the lead remains in service.No adverse patient effects were reported.Additional information indicated that there were no issues with the lead.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.This supplemental correction report was created to capture updates on h6: device codes and b5: describe event or problem and h6 device codes.
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Search Alerts/Recalls
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