MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Pacing Problem (1439); Pocket Stimulation (1463); Impedance Problem (2950)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this cardiac resynchronization therapy pacemaker was explanted following reported clinical observations of a decrease in impedance, stimulation, and loss of capture of an unreported duration.A lead insulation issue was suspected but an allegation that a potential unspecified device issue may have contributed to the necessity for explant was also made.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker was explanted following reported clinical observations of a decrease in impedance, stimulation, and loss of capture of an unreported duration on the left ventricular (lv) channel.The lv lead was from another manufacturer.A lead insulation issue was suspected but an allegation that a potential unspecified device issue may have contributed to the necessity for explant was also made.No additional adverse patient effects were reported.Following device return, a boston scientific technical services consultant performed analysis of device data.No device alerts were noted.Multiple stored episodes were reviewed and episodes for pacemaker mediated tachycardia and atrial tachycardia response appeared to be stored due to accelerated sinus activity.A small amount of baseline right ventricular noise was observed during both types of episodes; however, it was not oversensed by the device.One remote patient monitoring event was available which demonstrated a normal left ventricular electrogram with no evidence of noise or loss of capture.Left ventricular impedance was stable from implant the beginning of the year.Following that time, a gradual increase in left ventricular impedance measurements was observed with a peak that reached out-of-range levels.Subsequently, the left ventricular impedance abruptly decreased prior to device explant.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the crt-p was performed.The header was firmly attached to the device case.The setscrews moved freely, and a small hole was noted in the right ventricular seal plug.Engineering evaluation of device memory data indicated a normal rate of battery depletion.Impedance testing was performed on each channel and real-time electrograms were evaluated.Normal impedance measurements were observed in all chambers, and no electrogram noise was noted.A series of automated electrical/functional tests were conducted and no issues with device performance were observed; basic sensing and pacing functions of the device were verified.It was concluded that the device passed all testing and normal device operation was observed during laboratory analysis.Code 3191 (h6) is used to capture surgical intervention.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker was explanted following reported clinical observations of a decrease in impedance, stimulation, and loss of capture of an unreported duration on the left ventricular (lv) channel.The lv lead was from another manufacturer.A lead insulation issue was suspected but an allegation that a potential unspecified device issue may have contributed to the necessity for explant was also made.No additional adverse patient effects were reported.Following device return, a boston scientific technical services consultant performed analysis of device data.No device alerts were noted.Multiple stored episodes were reviewed and episodes for pacemaker mediated tachycardia and atrial tachycardia response appeared to be stored due to accelerated sinus activity.A small amount of baseline right ventricular noise was observed during both types of episodes; however, it was not oversensed by the device.One remote patient monitoring event was available which demonstrated a normal left ventricular electrogram with no evidence of noise or loss of capture.Left ventricular impedance was stable from implant the beginning of the year.Following that time, a gradual increase in left ventricular impedance measurements was observed with a peak that reached out-of-range levels.Subsequently, the left ventricular impedance abruptly decreased prior to device explant.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the crt-p was performed.The header was firmly attached to the device case.The setscrews moved freely, and a small hole was noted in the right ventricular seal plug.Engineering evaluation of device memory data indicated a normal rate of battery depletion.Impedance testing was performed on each channel and real-time electrograms were evaluated.Normal impedance measurements were observed in all chambers, and no electrogram noise was noted.A series of automated electrical/functional tests were conducted and no issues with device performance were observed; basic sensing and pacing functions of the device were verified.It was concluded that the device passed all testing and normal device operation was observed during laboratory analysis.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10021413
• MDR Text Key: 189756184
• Report Number: 2124215-2020-09976
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2021

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: Lay User/Patient
• Device Expiration Date: 12/17/2017
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 706255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 08/06/2020; 01/20/2021
• Supplement Dates FDA Received: 11/05/2020; 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR