ST. JUDE MEDICAL, INC. UNIFY QUADRA CRT-D, US MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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Model Number CD3249-40Q |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/10/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A decision was made on (b)(6) 2016 to report all prophylactic explants that are reported to st.Jude medical (sjm).Therefore, (b)(6) 2016 is used as the aware date for all prophylactic explants occurring prior to this date.Based on the information received, the device was prophylatically removed and there is no alleged malfunction of the product.Should the device be returned and the analysis results indicate an anomaly a follow up report will be submitted.(b)(4).
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Event Description
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Following the advisory for premature battery depletion with implantable cardioverter defibrillator, although there was no eri alert or allegation of premature battery depletion, the device was explanted prophylactically.
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Search Alerts/Recalls
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