MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U128

Device Problem Data Problem (3196)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

As no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode while implanted in the patient.Surgical intervention was performed and the crt-p was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.Visual inspection noted tool marks on the case and header, but identified no further anomalies.A review of the device memory noted two fault codes.The general diagnostics portion of the memory dump confirmed the double bit fault.After performing a telemetry reset the device went to primary operation and the device was observed to pass automated electrical testing.The allegation made against the device was confirmed through product testing.The device went into safety core due to the double bit faults.The cause of the memory corruption was unable to be determined.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode while implanted in the patient.Surgical intervention was performed and the crt-p was explanted and replaced.No additional adverse patient effects were reported.This product has just been returned back from the field for analysis.This report will be updated upon completion of analysis.

• Brand Name: VALITUDE X4 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: 9270227
• MDR Text Key: 164805008
• Report Number: 2124215-2019-23235
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• 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: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2021
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 741132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 11/02/2019
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 70 YR