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

Model Number F160

Device Problems Signal Artifact/Noise (1036); Under-Sensing (1661); Battery Problem (2885)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that this patient was admitted to the hospital due to multiple shocks.A request for estimated remaining longevity was needed to determine if the replacement date for the device should be expedited.Additional information noted that further review of the device data was requested from engineering to provide clarification remaining longevity.Meanwhile technical services (ts) review confirmed noise with no oversensing and no evidence of inappropriate therapy.However, undersensing was exhibited at times leading to unnecessary pacing.The device remains implanted.No adverse patient effects were reported.

Event Description

It was reported that this patient was admitted to the hospital due to multiple shocks.A request for estimated remaining longevity was needed to determine if the replacement date for the device should be expedited.Additional information noted that further review of the device data was requested from engineering to provide clarification remaining longevity.Meanwhile technical services (ts) review confirmed noise with no oversensing and no evidence of inappropriate therapy.However, undersensing was exhibited at times leading to unnecessary pacing.Additional information noted that the patient had a left ventricular assist device, which may be the reason for the reported noise artifacts.Ts noted that the left ventricular assist device may be contributing to the baseline noise seen, and also noted that it was likely that this device would trigger end of life (eol) in the very near future.Additional information noted that the patient was in the hospital due to a left ventricular assist device would infection and an inquiry regarding how long the implantable cardioverter defibrillator (icd) would support therapy and advise on the replacement window was needed.The device remains implanted.No adverse patient effects were reported.

• 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: 18990460
• MDR Text Key: 338801145
• Report Number: 2124215-2024-18805
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2012
• Device Model Number: F160
• Device Catalogue Number: F160
• Device Lot Number: 100223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 64 YR