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

Model Number L211

Device Problems Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problems Fainting (1847); Dizziness (2194); Syncope/Fainting (4411)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

It was reported that the patient implanted with this pacemaker was admitted to the coronary intensive care unit (icu) after reporting episodes of dizziness with fainting.The pacemaker was interrogated and a warning message was displayed on the programmer, indicating the device was operating in safety mode.The device settings were permanently limited to vvi mode pacing at 72 bpm, with an output of 5v.Technical services discussed the device would need to be explanted and replaced.The local field representative reported the device was explanted two days later.No additional adverse patient effects were reported.

Event Description

It was reported that the patient implanted with this pacemaker was admitted to the coronary intensive care unit (icu) after reporting episodes of dizziness with fainting.The pacemaker was interrogated and a warning message was displayed on the programmer, indicating the device was operating in safety mode.The device settings were permanently limited to vvi mode pacing at 72 bpm, with an output of 5v.Technical services discussed the device would need to be explanted and replaced.The local field representative reported the device was explanted two days later.No additional adverse patient effects were reported.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Interrogation of the device confirmed it was operating in safety mode and that brady therapy remained available.Review of device memory identified three faults recorded on (b)(6) 2019.The faults resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory, but the faults recurred, and the device reverted to safety mode again.The device case was opened and testing of the internal components found no anomalies.Detailed analysis revealed the memory faults were caused by a defective digital integrated circuit chip.

• 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
• MDR Report Key: 9225473
• MDR Text Key: 163400671
• Report Number: 2124215-2019-21969
• Device Sequence Number: 1
• Product Code: LWP
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/17/2020
• Device Model Number: L211
• Device Catalogue Number: L211
• Device Lot Number: 388482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 05/17/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention