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

Model Number L331

Device Problem Defective Device (2588)

Patient Problem Myocardial Infarction (1969)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the patient had a heart attack.Also, the patient mentioned of having numerous ekgs done at the hospital and the physician handed a report that stated unspecified pacemaker failure.Boston scientific technical services then referred patient back to the physician to discuss ekg report.This pacemaker remains in service.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the patient had a heart attack.Also, the patient mentioned of having numerous ekgs done at the hospital and the physician handed a report that stated unspecified pacemaker failure.Boston scientific technical services then referred patient back to the physician to discuss ekg report.This pacemaker remains in service.No adverse patient effects were reported.This supplemental report is being filed because additional information was received indicating that the patient was checked by the clinician and the device was functioning as expected.There was no pacer failure was noted.

• 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: 8314460
• MDR Text Key: 135348192
• Report Number: 2124215-2019-02443
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/23/2018
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 738185
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR