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

Model Number L321

Device Problem Premature Discharge of Battery (1057)

Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this pacemaker lasted only for less than five years.It was mentioned that the device was set high.No other information available.The device was explanted.No additional adverse patient effects were reported.

Event Description

It was reported that this pacemaker lasted only for less than five years.It was mentioned that the device was set high.No other information available.The device was explanted.No additional adverse patient effects were reported.Additional information obtained from the field which indicated that the suspected cause of this issue was due to elevated thresholds.Generator change was completed using chronic leads and patient was educated on reduced expectation of battery life.

Manufacturer Narrative

The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

• Brand Name: ACCOLADE 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
• MDR Report Key: 9995363
• MDR Text Key: 188819562
• Report Number: 2124215-2020-08843
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559242
• UDI-Public: 00802526559242
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

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: 10/29/2017
• Device Model Number: L321
• Device Catalogue Number: L321
• Device Lot Number: 707356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR