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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT HIGH VOLTAGE RV LEAD; DEFIBRILLATION LEAD
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ABBOTT HIGH VOLTAGE RV LEAD; DEFIBRILLATION LEAD Back to Search Results
Model Number HIGH VOLTAGE RV LEAD
Device Problem No Pacing (3268)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
Event Type  malfunction  
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
During a device upgrade procedure, it was reported that the right ventricular (rv) lead showed a loss of pacing following a polarity switch during positioning of the left ventricular (lv) lead.The patient was stable and there were no adverse consequences.
 
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Brand Name
HIGH VOLTAGE RV LEAD
Type of Device
DEFIBRILLATION LEAD
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key12248634
MDR Text Key266167686
Report Number2017865-2021-27063
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHIGH VOLTAGE RV LEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/16/2021
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
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