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

Model Number L231

Device Problems High impedance (1291); Use of Device Problem (1670); Data Problem (3196); Interrogation Problem (4017)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that a follow-up appointment, this implantable device did not show an electrocardiogram and no magnet response was observed.Upon further investigation, it was determined that this device was operating in storage mode and had not been programmed out of this mode prior to the implant procedure.The device was subsequently manually programmed out of storage mode and proper device function was observed.However, the right ventricular (rv) lead pacing impedance was noted to be high, and out of range (2300 ohms).All other parameters were stable.This information was forwarded to boston scientific technical services (ts) and it was discussed that while in storage mode, the device was only able to be interrogated/programmed and run a real-time clock.No pacing therapy was available.Luckily, the patient is not pacemaker-dependent and no adverse patient effects were reported due to the lack of therapy.Ts recommended continuing remote monitoring via latitude.At this time, the device remains implanted and in-service.

• 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: 18754858
• MDR Text Key: 336079874
• Report Number: 2124215-2024-10506
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L231
• Device Catalogue Number: L231
• Device Lot Number: 623596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1