Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT QUARTET LEAD SMALL-S, 75 CM; PERMANENT PACEMAKER ELECTRODE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT QUARTET LEAD SMALL-S, 75 CM; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1456Q/75
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/25/2020
Event Type  malfunction  
Manufacturer Narrative
This product is registered as a combination product.The results, method, and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
During initial implant procedure, the stylet was difficult to insert into the left ventricular (lv) lead.The lv lead was explanted and replaced to resolve the event.The patient was stable with no consequences.
 
Manufacturer Narrative
The reported event of stylet was difficult to insert into the lead was confirmed.As received, a complete lead was returned in one piece without the field stylet.Stylet insertion test found restriction/obstruction due to the inner coil clogged with dried blood/body fluid at the distal region of the lead.The cause of the reported event was isolated to the inner coil clogged with dried blood/body fluid.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUARTET LEAD SMALL-S, 75 CM
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key10145429
MDR Text Key194864212
Report Number2017865-2020-06732
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734510141
UDI-Public05414734510141
Combination Product (y/n)N
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 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2022
Device Model Number1456Q/75
Device Catalogue Number1456Q/75
Device Lot NumberA000082010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2020
Was the Report Sent to FDA? No
Date Manufacturer Received08/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-