MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number N140

Device Problems No Audible Alarm (1019); Premature Discharge of Battery (1057)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2020

Event Type  Injury  

Event Description

It was reported that this implantable cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.At this time, this crt-d remains in service, and there were no adverse patient effects reported.

Manufacturer Narrative

Patient code 3191 was applied to capture the reportable event of surgery.

Event Description

It was reported that this implantable cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.At this time, this product remains in-service, and there were no adverse patient effects reported.Additional information was received which indicated that this crt-d was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 was applied to capture the reportable event of surgery.The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alert (code 1003) was recorded, potentially indicative of early battery depletion.Analysis confirmed partial depletion, but the battery was still able to support full device function in the event that therapy would have been needed.The early depletion was caused by electrical leakage of a low voltage capacitor in the presence of excess hydrogen gas within the pulse generator case.

Event Description

It was reported that this implantable cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.At this time, this product remains in-service, and there were no adverse patient effects reported.Additional information was received which indicated that this crt-d was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ENERGEN CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11104389
• MDR Text Key: 224894917
• Report Number: 2124215-2020-25018
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: 00802526480959
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2016
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 115086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR