MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number E102

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2018

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) displayed a code 1005 indicative of an open circuit condition detected during shock delivery back in 2018.This patient was non-compliant with routine follow ups; therefore, the alert was detected during the most recent in office evaluation.Boston scientific technical services (ts) was consulted and upon review, it was noted this patient has received numerous other shocks since 2018.Out of range shock impedance measurements were observed.The patient was evaluated in clinic and reprogramming was performed.It was planned to perform a defibrillation threshold (dft) test and to provide this patient with a life vest, however, this patient did not show up to the procedure.A device changeout procedure has been scheduled.No adverse patient effects were reported.At this time, this device system remains in service.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) displayed a code 1005 indicative of an open circuit condition detected during shock delivery back in 2018.This patient was non-compliant with routine follow ups; therefore, the alert was detected during the most recent in office evaluation.Boston scientific technical services (ts) was consulted and upon review, it was noted this patient has received numerous other shocks since 2018.Out of range shock impedance measurements were observed.The patient was evaluated in clinic and reprogramming was performed.It was planned to perform a defibrillation threshold (dft) test and to provide this patient with a life vest, however, this patient did not show up to the procedure.A device changeout procedure has been scheduled.Additional information was received that a defibrillation threshold (dft) test was performed and out of range impedance measurements were obtained.The physician decided to perform a device changeout procedure and this icd was explanted and replaced.The right ventricular (rv) lead was capped and surgically abandoned.No additional adverse patient effects were reported.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) displayed a code 1005 indicative of an open circuit condition detected during shock delivery back in 2018.This patient was non-compliant with routine follow ups; therefore, the alert was detected during the most recent in office evaluation.Boston scientific technical services (ts) was consulted and upon review, it was noted this patient has received numerous other shocks since 2018.Out of range shock impedance measurements were observed.The patient was evaluated in clinic and reprogramming was performed.It was planned to perform a defibrillation threshold (dft) test and to provide this patient with a life vest, however, this patient did not show up to the procedure.A device changeout procedure has been scheduled.Additional information was received that a defibrillation threshold (dft) test was performed and out of range impedance measurements were obtained.The physician decided to perform a device changeout procedure and this icd was explanted and replaced.The right ventricular (rv) lead was capped and surgically abandoned.No additional adverse patient effects were reported.This device has been received for analysis.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Defibrillator and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16039754
• MDR Text Key: 307704569
• Report Number: 2124215-2022-54605
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

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: 06/02/2011
• Device Model Number: E102
• Device Catalogue Number: E102
• Device Lot Number: 257873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/15/2023; 11/09/2023
• Supplement Dates FDA Received: 02/20/2023; 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2010
• 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): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male