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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ABBOTT RIGHT ATRIAL LEAD; No Match
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ABBOTT ABBOTT RIGHT ATRIAL LEAD; No Match Back to Search Results
Model Number RA LEAD
Device Problems Break (1069); Over-Sensing (1438)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2024
Event Type  malfunction  
Event Description
During a remote follow-up, noise that resulted in oversensing was noted on the right atrial (ra) lead.Insulation damage was suspected but was not confirmed.No intervention was performed and the patient was stable and will continue to be monitored.
 
Manufacturer Narrative
Further information was requested but not received.
 
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Brand Name
ABBOTT RIGHT ATRIAL LEAD
Type of Device
No Match
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key18989124
MDR Text Key338737206
Report Number2017865-2024-37055
Device Sequence Number1
Product Code NVN
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRA LEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/12/2024
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 Sequence Number1
Treatment
ABBOTT RIGHT VENTRICULAR LEAD; ENDURITY MRI
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