MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U225

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Communication or Transmission Problem (2896)

Patient Problem Syncope/Fainting (4411)

Event Date 01/07/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had connection issues with the latitude monitor system.During the interrogation at the hospital, the patient lost consciousness and the crt-p was found to be in safety mode.Pacing inhibition, greater than two seconds, was suspected to be the cause of the syncopal event.The device was then successfully explanted.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had connection issues with the latitude monitor system.During the interrogation at the hospital, the patient lost consciousness and the crt-p was found to be in safety mode.Pacing inhibition, greater than two seconds, was suspected to be the cause of the syncopal event.The device was then successfully explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was operating in safety mode.Attempts to perform a memory download was unsuccessful as the memory was completely corrupted.New firmware was downloaded into memory and the device returned to primary operation with nominal settings.The device case was opened, and an external power supply was connected to the device.No high output conditions were observed.High powered visual inspection of the device header and case found no evidence of electrocautery marks.The battery was removed from the device and sent for analysis; no battery issues were observed.Analysis concluded that the safety mode was due to a corrupted memory however the cause of the corruption could not be determined.

• Brand Name: VISIONIST CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11729843
• MDR Text Key: 247477672
• Report Number: 2124215-2021-10238
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: 00802526559426
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S138
• 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: 10/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/09/2017
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 701014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Date Manufacturer Received: 07/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR