Model Number 1457Q/86 |
Device Problems
Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
Injury
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Manufacturer Narrative
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This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that the patient presented to the clinic for a follow up.Interrogation showed the patient's left ventricular (lv) lead capture threshold was high.A chest x-ray was performed which showed the lv lead had dislodged.The patient was asymptomatic.No changes have been made.
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Event Description
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Additional information received indicated that the patient's left ventricular lead was programmed off.
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Manufacturer Narrative
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Additional information: b1, b2, b5, d7, h1.
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Event Description
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Additional information received indicated that the patient's left ventricular lead was explanted and replaced.The patient was stable throughout.
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Search Alerts/Recalls
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