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

Model Number L231

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

It was reported that prior to unboxing this device, an interrogation revealed the device was in storage mode.The device was never opened and is intended to be returned for laboratory analysis.No patient involvement.

Manufacturer Narrative

Following return and completion of laboratory analysis, this event will be further updated.

Manufacturer Narrative

This report is being filed to correct describe event or problem.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.

Event Description

It was reported that prior to unboxing this device, an interrogation revealed the device was in safety mode.The device was never opened and is intended to be returned for laboratory analysis.No patient involvement.

• Brand Name: PROPONENT 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
• 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: 11227879
• MDR Text Key: 241236475
• Report Number: 2124215-2020-29001
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2022
• Device Model Number: L231
• Device Catalogue Number: L231
• Device Lot Number: 906402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 02/22/2022
• Supplement Dates FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1