Model Number 2088TC/52 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/29/2020 |
Event Type
malfunction
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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 for an implant procedure.During the procedure, the atrial lead to be implanted could not to be fixed.The lead was replaced during the procedure on (b)(6) 2020.Patient was stable.
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Manufacturer Narrative
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The damage found was sustained during procedure.The lead was otherwise normal.
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Search Alerts/Recalls
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