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

Model Number V173

Device Problems Premature Discharge of Battery (1057); Pacing Problem (1439); Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Bradycardia (1751); Nausea (1970); Dizziness (2194); No Code Available (3191)

Event Date 01/10/2021

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room with dizziness, nausea, light-headedness and pocket stimulation.The device was interrogated and found to be in safety mode.The patient symptoms were noted to be due to pacing inhibition.It was unknown if the patient had any medical procedures that might have caused the change to safety mode.Subsequently, the patient underwent a revision procedure and this device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room with dizziness, nausea, light-headedness and pocket stimulation.The device was interrogated and found to be in safety mode.The patient symptoms were noted to be due to pacing inhibition.It was unknown if the patient had any medical procedures that might have caused the change to safety mode.Subsequently, the patient underwent a revision procedure and this device was explanted and replaced.No additional adverse patient effects were reported.Additional information was received from the health care professional suspecting premature battery depletion.The cardiac resynchronization therapy pacemaker hit elective replacement indicator and the clinic never got an alert.The patient presented to the hospital two days after this.No additional adverse patient effects were reported.

Manufacturer Narrative

The device has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) presented to the emergency room with dizziness, nausea, light-headedness and pocket stimulation.The device was interrogated and found to be in safety mode.The patient symptoms were noted to be due to pacing inhibition.It was unknown if the patient had any medical procedures that might have caused the change to safety mode.Subsequently, the patient underwent a revision procedure and this device was explanted and replaced.No additional adverse patient effects were reported.Additional information was received from the health care professional suspecting premature battery depletion.The cardiac resynchronization therapy pacemaker hit elective replacement indicator and the clinic never got an alert.The patient presented to the hospital two days after this.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 due to system resets.It was confirmed that brady therapy remained available.The system resets occurred during a telemetry session and caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.

• 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: 11227922
• MDR Text Key: 241236452
• Report Number: 2124215-2021-01771
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2021

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: 01/11/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 105383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/26/2021; 09/28/2021
• Supplement Dates FDA Received: 02/21/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR