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: MEDTRONIC HEART VALVES DIVISION STREAMLINE BIPOLAR TEMPORARY 6495 PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY
  • 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
 

MEDTRONIC HEART VALVES DIVISION STREAMLINE BIPOLAR TEMPORARY 6495 PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 6495
Device Problems Break (1069); Disconnection (1171)
Patient Problem Loss of consciousness (2418)
Event Date 02/06/2019
Event Type  Injury  
Event Description
An elderly female with history of diabetes, atrial fibrillation had mitral valve replacement, tricuspid valve repair, clipping of left atrial appendage and left side cryo-maze with placement of atrioventricular pacer wires for severe mitral valve stenosis, severely dilated tricuspid valve annulus.The next day during the 3a-3p shift, patient was sitting on the side of the bed, and went unconscious, falling back on the bed.It was then discovered that the pacing wire disconnected from gray cables causing the patient to lose heart rhythm and consciousness for about 40 seconds as she was pacer dependent post op.She received no meds, cpr or compressions.When wire was attempted to be placed back into connector, it was found to be too short and broken off.Nurse manually held the wire in the connector for about 15 minutes until the electrophysiology physician could come and see the patient.The physician adjusted the wire and secured it with tape.Patient scheduled for permanent pacer placement the next day.It is not known whether the post was not fully inserted into the cable and it broke off or if it was fully inserted but had been tightened too tight to cause it to break.Please see photos for the size of the broken piece.We have no identifying product information from the device, as all packaging discarded.
 
Event Description
An elderly female with history of diabetes, atrial fibrillation had mitral valve replacement, tricuspid valve repair, clipping of left atrial appendage and left side cryo-maze with placement of atrioventricular pacer wires for severe mitral valve stenosis, severely dilated tricuspid valve annulus.The next day during the 3a-3p shift, patient was sitting on the side of the bed, and went unconscious, falling back on the bed.It was then discovered that the pacing wire disconnected from gray cables causing the patient to lose heart rhythm and consciousness for about 40 seconds as she was pacer dependent post op.She received no meds, cpr or compressions.When wire was attempted to be placed back into connector, it was found to be too short and broken off.Nurse manually held the wire in the connector for about 15 minutes until the electrophysiology physician could come and see the patient.The physician adjusted the wire and secured it with tape.Patient scheduled for permanent pacer placement the next day.It is not known whether the post was not fully inserted into the cable and it broke off or if it was fully inserted but had been tightened too tight to cause it to break.Please see photos for the size of the broken piece.We have no identifying product information from the device, as all packaging discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STREAMLINE BIPOLAR TEMPORARY 6495 PACING LEAD
Type of Device
ELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 east deere ave.
santa ana CA 92705
MDR Report Key8353499
MDR Text Key136609452
Report Number8353499
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 02/11/2019,02/07/2019
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 Operator No Information
Device Model Number6495
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2019
Event Location Hospital
Date Report to Manufacturer02/20/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/20/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age22630 DA
-
-