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

Model Number L331

Device Problems Pacing Problem (1439); Inaccurate Synchronization (1609); Under-Sensing (1661)

Patient Problem Ventricular Tachycardia (2132)

Event Date 05/23/2020

Event Type  Injury  

Event Description

It was reported that this pacemaker undersensed a single ventricular beat.A pace was then delivered on a t-wave and induced the patient into a ventricular tachycardia (vt).The rhythm did convert on its own.Boston scientific technical services (ts) discussed programming options for optimization of sensing.Available information indicates this product remains implanted and in service.No additional adverse patient effects were reported.

Event Description

It was reported that programming changes were made for optimization of sensitivity and monitoring will be continued.

• Brand Name: ACCOLADE MRI 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: 10236172
• MDR Text Key: 197667878
• Report Number: 2124215-2020-11644
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• Combination Product (y/n): N
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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: 03/27/2019
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 749293
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR