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

Model Number E143

Device Problems Failure to Capture (1081); High Capture Threshold (3266)

Patient Problems Atrial Flutter (1730); Atrial Tachycardia (1731); Seizures (2063); Complete Heart Block (2627)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

This investigation will be updated should further information be provided.

Event Description

It was reported that this patient had a cardioversion for atrial flutter (af) one week ago and his amiodarone was doubled post conversion.Today, the patient presented to the emergency room due to seizures on his right side.Evaluation of the patient noted complete heart block (chb) and a history of intermittent and variable intrinsic beats with junctional rhythms.The patient was in an atrial arrhythmia at a rate of 120 bpm.System evaluation identified no capture and elevated threshold measurements on the right ventricular (rv) channel.A boston scientific technical services consultant documented and discussed the clinical observations with the caller.A review of the stored data confirmed stable impedance measurements and with varying sensing measurements over the past eight months.The consultant discussed the possibility that patient factors could be contributing to reported clinical observations given the seizures are not part of this patient's past history.Further evaluation was recommended.No adverse patient effects were reported.

• 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8859835
• MDR Text Key: 153236787
• Report Number: 2124215-2019-16061
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480744
• UDI-Public: 00802526480744
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2019

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: 11/12/2014
• Device Model Number: E143
• Device Catalogue Number: E143
• Device Lot Number: 105623
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 93 YR