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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE
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ABBOTT QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/86
Device Problem Intermittent Capture (1080)
Patient Problem Syncope/Fainting (4411)
Event Date 08/28/2021
Event Type  Injury  
Event Description
Related manufacturer reference number: 2017865-2021-29735; 2017865-2021-29737.It was reported that a loss of capture was observed on the left ventricular (lv) lead.The patient experienced syncope due to the event.The lv lead was explanted and replaced to resolve the event.The patient was stable.
 
Manufacturer Narrative
The reported event of intermittent capture was not confirmed.As received, a complete lead was returned in one piece.Visual and x-ray examination of the lead did not find any anomalies.Electrical testing did not find any indication of conductor fractures or internal shorts.The s-curve was measured to be within specification.
 
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Brand Name
QUARTET
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key12470989
MDR Text Key271376820
Report Number2017865-2021-29738
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503198
UDI-Public05414734503198
Combination Product (y/n)Y
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model Number1458Q/86
Device Catalogue Number1458Q-86
Device Lot NumberS000077739
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2021
Was the Report Sent to FDA? No
Date Manufacturer Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
OPTISURE ACTIVE FIXATION; QUADRA ASSURA MP ICD; OPTISURE ACTIVE FIXATION; QUADRA ASSURA MP ICD
Patient Outcome(s) Required Intervention;
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