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

Model Number E141

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)

Patient Problem Electric Shock (2554)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

It was reported that this patient with this implantable cardioverter defibrillator (icd) experienced an arrhythmia.Anti-tachycardia pacing (atp) and 1 shock was delivered, which slowed the rate.Upon review, technical services (ts) noted therapy was withheld for the first minute or so and then uncorrelated decision made likely due to premature ventricular contraction and some noise on shock channel.Ts noted this rhythm was likely atrial fibrillation (af) with rapid ventricular response (rvr), and not ventricular tachycardia (vt).This icd remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENERGEN 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: 15798546
• MDR Text Key: 303750897
• Report Number: 2124215-2022-47200
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480720
• UDI-Public: 00802526480720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S235
• 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
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2015
• Device Model Number: E141
• Device Catalogue Number: E141
• Device Lot Number: 119779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2013
• 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 Age: 79 YR
• Patient Sex: Male