MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESSENTIO EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number L121

Device Problems Battery Problem (2885); Power Problem (3010); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected.Detailed analysis confirmed that a high current drain was the result of a compromised capacitor, which resulted in the observed premature battery depletion.Investigation has determined that the high current drain is the result of compromised low voltage capacitors, which is caused by the presence of excess hydrogen from a liner component within the device.

Event Description

It was reported this pacemaker exhibited significant drop in longevity.Analysis showed that the battery diagnostic data indicated that the power consumption of this device has been increasing for over a year.The malfunction appeared consistent with other pulse generator that have had continuous average power increases.The device was explanted.No additional adverse patient effects were reported.

• Brand Name: ESSENTIO EL DR
• 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: 9649761
• MDR Text Key: 177124025
• Report Number: 2124215-2020-02035
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526558986
• UDI-Public: 00802526558986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/15/2017
• Device Model Number: L121
• Device Catalogue Number: L121
• Device Lot Number: 702589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR