MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE DEVICE

Model Number F102

Device Problems Device Alarm System (1012); Premature Discharge of Battery (1057)

Patient Problem Anxiety (2328)

Event Date 12/04/2021

Event Type  Injury  

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed and data analysis showed the battery appeared to be depleting more quickly than expected.At the previous interrogation, device longevity was two years and the current longevity was three months.It was noted that the patient also had a left-ventricular assist device in place.The device was emitting tones every six hours, which was causing stress and anxiety for the patient.Technical services discussed that the tones emitted from the device with respect to this condition are not a programmable feature.It was not planned to replace the device as the patient was placed on the heart transplant list.When eventually explanted, the device is expected to be returned to boston scientific for analysis.

Manufacturer Narrative

The returned implantable cardioverter defibrillator was analyzed and it was confirmed that the device recorded code 1003.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.Boston scientific has concluded that this device experienced normal battery depletion.

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed and data analysis showed the battery appeared to be depleting more quickly than expected.At the previous interrogation, device longevity was two years and the current longevity was three months.It was noted that the patient also had a left-ventricular assist device in place.The device was emitting tones every six hours, which was causing stress and anxiety for the patient.Technical services discussed that the tones emitted from the device with respect to this condition are not a programmable feature.It was not planned to replace the device as the patient was placed on the heart transplant list.When eventually explanted, the device is expected to be returned to boston scientific for analysis.It was additionally reported that the device was replaced.Boston scientific has received the device for analysis.

Event Description

It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed and data analysis showed the battery appeared to be depleting more quickly than expected.At the previous interrogation, device longevity was two years and the current longevity was three months.It was noted that the patient also had a left-ventricular assist device in place.The device was emitting tones every six hours, which was causing stress and anxiety for the patient.Technical services discussed that the tones emitted from the device with respect to this condition are not a programmable feature.It was not planned to replace the device as the patient was placed on the heart transplant list.When eventually explanted, the device is expected to be returned to boston scientific for analysis.It was additionally reported that the device was replaced.Boston scientific has received the device for analysis.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE DEVICE
• 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: 13445414
• MDR Text Key: 285220177
• Report Number: 2124215-2021-40877
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/06/2012
• Device Model Number: F102
• Device Catalogue Number: F102
• Device Lot Number: 113933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention