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

Model Number L211

Device Problems Failure to Sense (1559); Defective Device (2588); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2022

Event Type  malfunction  

Event Description

It was reported that this pacemaker was an attempted implant due to damage or defectiveness.When the physician connected the catheters to this device, the signal did not appear on the programmer screen.There was no physical damage on the pacemaker however it was suspected that there was an electrical issue or connection problem.Subsequently, another pacemaker was implanted.No adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.A review of the device memory noted the device was still in storage mode.There were no fault codes in the memory.The timeline and episode history noted that on 18-june-2022, the day of attempted implant, a telemetry session was noted and however there was no programming command to exit storage mode.The device communicated normally with the 3300 programmer.The device was confirmed to be in storage mode.Electrocardiograms (egm) and event markers are not active in storage mode.Pacing and sensing are not active in storage mode.The device was programmed out of storage mode and egms and event markers were immediately noted.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.

Event Description

It was reported that this pacemaker was an attempted implant due to damage or defectiveness.When the physician connected the catheters to this device, the signal did not appear on the programmer screen.There was no physical damage on the pacemaker however it was suspected that there was an electrical issue or connection problem.Subsequently, another pacemaker was implanted.No adverse patient effects were reported.

• Brand Name: PROPONENT MRI 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: 14940471
• MDR Text Key: 295417384
• Report Number: 2124215-2022-24401
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L211
• Device Catalogue Number: L211
• Device Lot Number: 631346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1