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

Model Number E162

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540); Defective Device (2588)

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

Event Date 02/20/2022

Event Type  Injury  

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) presented to the emergency department and received 3 unsuccessful appropriate shock therapy for ventricular fibrillation and the 4th shock was aborted with spontaneous reversion.The rhythm ended up terminating on its own, with no external intervention.The patient had reported that she had forgotten to take her medication.X-ray imaging and data were provided for review.Additionally, the device recorded high shock impedance measurement, measuring greater than 125 ohms.Boston scientific technical services consultant discussed programming options and indicated that the x-ray indicate that the coil was not well positioned up against the septum which may be a contributing factor to high defibrillation threshold testing (dft) and suggested possibly a lead revision is necessary.No additional adverse patient effects were reported.This device and right ventricular (rv) lead remains in service.Additional information was provided, it was reported that on (b)(6) 2022 the patient was seen for a follow-up, an induction in reversed polarity was performed and revealed two code 1005, indicating an open circuit condition.Both shocks were successful but the measurement was greater than 145 ohms.The device was set back to polarity and four dft were performed and were all successful with measurement at 110 ohms.Boston scientific technical services consultant recommended generator and lead replacement.The patient was referred to (b)(6) hospital for review and assessment for lead extraction.Additionally, this icd and rv lead were explanted and replaced with a competitor.No additional adverse patient effects were reported.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) presented to the emergency department and received 3 unsuccessful appropriate shock therapy for ventricular fibrillation and the 4th shock was aborted with spontaneous reversion.The rhythm ended up terminating on its own, with no external intervention.The patient had reported that she had forgotten to take her medication.X-ray imaging and data were provided for review.Additionally, the device recorded high shock impedance measurement, measuring greater than 125 ohms.Boston scientific technical services consultant discussed programming options and indicated that the x-ray indicate that the coil was not well positioned up against the septum which may be a contributing factor to high defibrillation threshold testing (dft) and suggested possibly a lead revision is necessary.No additional adverse patient effects were reported.This device and right ventricular (rv) lead remains in service.Additional information was provided, it was reported that on 09mar2022 the patient was seen for a follow-up, an induction in reversed polarity was performed and revealed two code 1005, indicating an open circuit condition.Both shocks were successful but the measurement was greater than 145 ohms.The device was set back to polarity and four dft were performed and were all successful with measurement at 110 ohms.Boston scientific technical services consultant recommended generator and lead replacement.The patient was referred to auckland city hospital for review and assessment for lead extraction.Additionally, this icd and rv lead were explanted and replaced with a competitor.No additional adverse patient effects were reported.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) presented to the emergency department and received 3 unsuccessful appropriate shock therapy for ventricular fibrillation and the 4th shock was aborted with spontaneous reversion.The rhythm ended up terminating on its own, with no external intervention.The patient had reported that she had forgotten to take her medication.X-ray imaging and data were provided for review.Additionally, the device recorded high shock impedance measurement, measuring greater than 125 ohms.Boston scientific technical services consultant discussed programming options and indicated that the x-ray indicate that the coil was not well positioned up against the septum which may be a contributing factor to high defibrillation threshold testing (dft) and suggested possibly a lead revision is necessary.No additional adverse patient effects were reported.This device and right ventricular (rv) lead remains in service.Additional information was provided, it was reported that on (b)(6) 2022 the patient was seen for a follow-up, an induction in reversed polarity was performed and revealed two code 1005, indicating an open circuit condition.Both shocks were successful but the measurement was greater than 145 ohms.The device was set back to polarity and four dft were performed and were all successful with measurement at 110 ohms.Boston scientific technical services consultant recommended generator and lead replacement.The patient was referred to (b)(6) hospital for review and assessment for lead extraction.Additionally, this icd and rv lead were explanted and replaced with a competitor.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned implantable cardioverter defibrillator (icd) was analyzed.The battery voltage was lower than expected.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device battery.Low voltage capacitors are used in the high voltage charging operation in order to facilitate fast charge times.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.

• Brand Name: INCEPTA ICD
• 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: 14067943
• MDR Text Key: 289018124
• Report Number: 2124215-2022-08130
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: 00802526480775
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P960040/S235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/23/2014
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 102900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 19 YR
• Patient Sex: Female