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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; PERMANENT PACEMAKER ELECTRODE
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BOSTON SCIENTIFIC CORPORATION FINELINE II EZ STEROX; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 4469
Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a device changeout procedure, the new cardiac resynchronization therapy defibrillator (crt-d) and the right ventricular (rv) lead exhibited high out-of-range shock impedance measurements greater than 200 ohms.All df-1 pins and the lv lead were removed and re-inserted.After doing so, shock impedance measurements were in range at 80 ohms.Rv coil to can was in the 60 ohm range.The ra coil was in the 100-ohm range, however it had been in this range historically.There was some rate/sense noise upon pocket closure, and it was believed that pocket closure was the cause of that noise.Following the device replacement procedure, this left ventricular (lv) lead exhibited no capture.Low level noise was also observed on the rv channel, and it was noted that this may have been attributed to external monitoring equipment hooked up to the patient.Rv auto-threshold (rvat) testing showed no capture due to no evoked response (er) on the shock electrogram (egm) at maximum outputs.In addition, there were premature ventricular contractions (pvcs) marked as rv deflections with no corresponding qrs on the shock egm.Right atrial (ra) lead auto-threshold (raat) testing resulted in a qrs on the shock egm.The patient was brought to the catheterization laboratory, and it was confirmed that the is-1 pins of the ra and rv lead were reversed in the header of the new crt-d.Before correcting the reversed ra and rv lead connections, lv thresholds were checked in ddd.It was determined that because the rv lead was in the atrial port, rv pacing left the lv in refractory resulting in the lv capture threshold issues.The pocket was re-opened that same day to correct the ra and rv is-1 connections.Once the lead connections were corrected, lv thresholds and all tests had resolved.This crt-d, rv lead, ra lead, and lv lead remain in service.No additional adverse patient effects were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a device changeout procedure, the new cardiac resynchronization therapy defibrillator (crt-d) and the right ventricular (rv) lead exhibited high out-of-range shock impedance measurements greater than 200 ohms.All df-1 pins and the lv lead were removed and re-inserted.After doing so, shock impedance measurements were in range at 80 ohms.Rv coil to can was in the 60 ohm range.The ra coil was in the 100-ohm range, however it had been in this range historically.There was some rate/sense noise upon pocket closure, and it was believed that pocket closure was the cause of that noise.Following the device replacement procedure, this left ventricular (lv) lead exhibited no capture.Low level noise was also observed on the rv channel, and it was noted that this may have been attributed to external monitoring equipment hooked up to the patient.Rv auto-threshold (rvat) testing showed no capture due to no evoked response (er) on the shock electrogram (egm) at maximum outputs.In addition, there were premature ventricular contractions (pvcs) marked as rv deflections with no corresponding qrs on the shock egm.Right atrial (ra) lead auto-threshold (raat) testing resulted in a qrs on the shock egm.The patient was brought to the catheterization laboratory, and it was confirmed that the is-1 pins of the ra and rv lead were reversed in the header of the new crt-d.Before correcting the reversed ra and rv lead connections, lv thresholds were checked in ddd.It was determined that because the rv lead was in the atrial port, rv pacing left the lv in refractory resulting in the lv capture threshold issues.The pocket was re-opened that same day to correct the ra and rv is-1 connections.Once the lead connections were corrected, lv thresholds and all tests had resolved.This crt-d, rv lead, ra lead, and lv lead remain in service.No additional adverse patient effects were reported.
 
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Brand Name
FINELINE II EZ STEROX
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key12112207
MDR Text Key260024020
Report Number2124215-2021-14503
Device Sequence Number1
Product Code DTB
Combination Product (y/n)Y
PMA/PMN Number
P960004/S014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/02/2009
Device Model Number4469
Device Catalogue Number4469
Was Device Available for Evaluation? No
Date Manufacturer Received06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age78 YR
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