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

Model Number V173

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Syncope (1610); No Code Available (3191)

Event Date 04/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had reached elective replacement indicator, and then a few days later the device was interrogated and found that the device had three memory errors that put it into safety core.The device was operating at vvi 72.5ppm, and the sensing was unipolar while in in safety core that was causing noise.A few days later the patient presented to the emergency room due to syncope.Subsequently, the patient underwent a revision procedure and this device was explanted and replaced.The device was planned to be returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had reached elective replacement indicator, and then a few days later the device was interrogated and found that the device had three memory errors that put it into safety core.The device was operating at vvi 72.5ppm, and the sensing was unipolar while in safety core that was causing noise.A few days later the patient presented to the emergency room due to syncope.Subsequently, the patient underwent a revision procedure and this device was explanted and replaced.The device was planned to be returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that both brady and tachy therapy remained available.Review of device memory identified an error that resulted in software resets performed in an attempt to correct an identified inconsistency.The battery was removed and detailed analysis was able to confirm the cell had a high internal resistance.The cause of the high resistance within the cell has not been determined, however likely resulted in the device error code and operation in safety mode.3191 code was used to denote surgical intervention.

• Brand Name: INVIVE
• 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: 10225324
• MDR Text Key: 197347753
• Report Number: 2124215-2020-10499
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 104097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Date Manufacturer Received: 10/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR