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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR; PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number CD1411-36Q
Device Problems Failure to Charge (1085); Inappropriate or Unexpected Reset (2959); Interrogation Problem (4017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2023
Event Type  Injury  
Event Description
It was reported that the implantable cardioverter defibrillator exhibited backup operation.It was noted that the capacitor maintenance timed out and there was an interrogation problem.It was also mentioned that the right ventricular lead exhibited failure to capture, failure to sense and high impedance due to fracture.The lead and the device were both explanted.The patient was in stable condition.
 
Manufacturer Narrative
The reported event of reset due to por (power-on-reset) and charge timeout were confirmed.The reported event of interrogation problem was not confirmed.Por and charge timeout were due to excessive charges and low battery voltage.The device image was reviewed by tech services and the device behaved as programmed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.A longevity calculation was performed and found the battery depletion was normal based on the device usage.
 
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Brand Name
ELLIPSE VR
Type of Device
PULSE GENERATOR, PERMANENT, IMPLANTABLE
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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key17892491
MDR Text Key325226565
Report Number2017865-2023-48001
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier05414734507738
UDI-Public05414734507738
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Expiration Date03/31/2017
Device Model NumberCD1411-36Q
Device Lot NumberA000003839
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/15/2023
Initial Date FDA Received10/06/2023
Supplement Dates Manufacturer Received02/19/2024
Supplement Dates FDA Received03/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
Patient SexMale
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