MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number E102

Device Problems Device Alarm System (1012); Signal Artifact/Noise (1036); Over-Sensing (1438); Battery Problem (2885); High Capture Threshold (3266); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  Injury  

Event Description

It was reported that this device was emitting tones and elective replacement indicator (eri) was triggered.Additionally, an episode of noise and oversensing was identified.The caller was inquiring about device longevity as it was observed to be ten months two days prior after increasing the right ventricular (rv) output.The caller stated there was no rv pacing and inquired how the device could reach eri if there was no pacing therapy.A boston scientific technical services consultant documented and discussed the reported clinical observations.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pin gage testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this device was emitting tones and elective replacement indicator (eri) was triggered.Additionally, an episode of noise and oversensing was identified.The caller was inquiring about device longevity as it was observed to be ten months two days prior after increasing the right ventricular (rv) output.The caller stated there was no rv pacing and inquired how the device could reach eri if there was no pacing therapy.A boston scientific technical services consultant documented and discussed the reported clinical observations.No adverse patient effects were reported.It was reported that this device was subsequently explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this device was emitting tones and elective replacement indicator (eri) was triggered.Additionally, an episode of noise and oversensing was identified.The caller was inquiring about device longevity as it was observed to be ten months two days prior after increasing the right ventricular (rv) output.The caller stated there was no rv pacing and inquired how the device could reach eri if there was no pacing therapy.A boston scientific technical services consultant documented and discussed the reported clinical observations.No adverse patient effects were reported.It was reported that this device was subsequently explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13502455
• MDR Text Key: 285470416
• Report Number: 2124215-2022-04184
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2022

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: 06/04/2010
• Device Model Number: E102
• Device Catalogue Number: E102
• Device Lot Number: 243923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 02/18/2022; 04/08/2022
• Supplement Dates FDA Received: 04/05/2022; 05/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male