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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CRT-P

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CRT-P Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombus (2101)
Event Date 04/30/2019
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
Related manufacturer reference numbers: 2017865-2019-08633, 2017865-2019-08634, and 2017865-2019-08635. It was reported that the patient presented for system implant. When sheath was attempted for the removal, the left ventricular lead dislodged, and threshold did not meet the requirements. A new sheath was used; however, it was unsuccessful. The operation took five hours. The patient suffered from acute left heart failure with sudden drop in blood oxygen saturation and blood pressure. The physician believed that the patient¿s complication was not due to implant products. The procedure was suspended. The patient was noted with thrombus in the right ventricle. The patient was stable after the procedure.
 
Manufacturer Narrative
Upon review of the new information received on june 1, 2019, the device should not have been submitted as a medical device report (mdr) as it was never used during the procedure.
 
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Type of DeviceCRT-P
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8641608
MDR Text Key146106478
Report Number2017865-2019-08638
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/24/2019 Patient Sequence Number: 1
Treatment
QUARTET LEAD; TENDRIL ST LEAD; TENDRIL ST LEAD
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