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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3231-40
Device Problem Delayed Charge Time (2586)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2019
Event Type  Injury  
Manufacturer Narrative
The results/ method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the patient presented remotely via merlin.Net.Review of the transmission revealed the implantable cardioverter defibrillator exhibited long charge time per report after the patient received multiple therapies.The device was explanted and replaced.The patient was in stable condition.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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Brand Name
UNIFY CRT-D
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key9286794
MDR Text Key165312665
Report Number2017865-2019-16030
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734504362
UDI-Public05414734504362
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2012
Device Model NumberCD3231-40
Device Catalogue NumberCD3231-40
Device Lot Number3245045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Was the Report Sent to FDA? No
Date Manufacturer Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
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