Model Number V173 |
Device Problems
Premature Discharge of Battery (1057); High impedance (1291)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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If additional information is received a supplemental report will be submitted.
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Event Description
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It was reported that the healthcare professional questioned a suspected decrease in device longevity on this cardiac resynchronization therapy pacemaker.Disk analysis was performed in which it was confirmed that the device was consuming higher amount of power due to the high rate atrial sensing.Technical services discussed to consider programming the atrial sensing lead off.It was also noted that there were elevated left ventricular pace impedance measurements of greater than 2,000 ohms.The following day the impedances suddenly decreased to within range to 1,000 ohms.The device remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that the health care professional questioned a suspected decrease in device longevity on this cardiac resynchronization therapy pacemaker.Disk analysis was performed in which it was confirmed that the device was consuming higher amount of power due to the high rate atrial sensing.Technical services discussed to consider programming the atrial sensing lead off.It was also noted that there were elevated left ventricular pace impedance measurements of greater than 2,000 ohms.The following day the impedances suddenly decreased to within range to 1,000 ohms.The device remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited sensing of chronic high atrial rates which may impact battery longevity over time.Please refer to the description for more information regarding the specific circumstances of this event.
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited sensing of chronic high atrial rates which may impact battery longevity over time.Please refer to the description for more information regarding the specific circumstances of this event.
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Event Description
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It was reported that the health care professional questioned a suspected decrease in device longevity on this cardiac resynchronization therapy pacemaker.Disk analysis was performed in which it was confirmed that the device was consuming higher amount of power due to the high rate atrial sensing.Technical services discussed to consider programming the atrial sensing lead off.It was also noted that there were elevated left ventricular pace impedance measurements of greater than 2,000 ohms.The following day the impedances suddenly decreased to within range to 1,000 ohms.The device remains in service.No adverse patient effects were reported.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited sensing of chronic high atrial rates which may impact battery longevity over time.Please refer to the description for more information regarding the specific circumstances of this event.Additional information was received that this crt-p was explanted due to advisory.A new device was implanted and remains in service.No additional adverse patient effects were reported.
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Event Description
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It was reported that the health care professional questioned a suspected decrease in device longevity on this cardiac resynchronization therapy pacemaker.Disk analysis was performed in which it was confirmed that the device was consuming higher amount of power due to the high rate atrial sensing.Technical services discussed to consider programming the atrial sensing lead off.It was also noted that there were elevated left ventricular pace impedance measurements of greater than 2,000 ohms.The following day the impedances suddenly decreased to within range to 1,000 ohms.The device remains in service.No adverse patient effects were reported.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited sensing of chronic high atrial rates which may impact battery longevity over time.Please refer to the description for more information regarding the specific circumstances of this event.Additional information was received that this crt-p was explanted due to advisory.A new device was implanted and remains in service.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited sensing of chronic high atrial rates which may impact battery longevity over time.Please refer to the description for more information regarding the specific circumstances of this event.The returned cardiac resynchronization therapy pacemaker was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
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Search Alerts/Recalls
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