MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE DEVICE

Model Number V173

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information indicates this device is currently in the possession of the explanting hospital.This investigation will be updated should further information be provided.

Event Description

It was reported that a remote monitoring transmission was received by the healthcare provider (hcp) which indicated that this cardiac resynchronization therapy pacemaker (crt-p) device had reverted to safety mode with limited critical therapy still available.Boston scientific technical services (ts) discussed with the hcp what safety mode means, indicated that the device needs to be replaced and suggested talking with the patient about any exposure to radiation or other things that may have caused the device to revert to safety mode.The hcp noted that the patient is pace therapy dependent and indicated that they will review this issue with the physician.The device was subsequently explanted and replaced three (3) days later.As part of this replacement procedure, the device was interrogated, and the safety mode codes that were observed all indicate a device memory issue.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery.Information indicates this device is currently in the possession of the explanting hospital.This investigation will be updated should further information be provided.The device was returned to boston scientific and device analysis was completed.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A review of device memory confirmed it was operating in safety mode and brady therapy remained available while implanted.The memory review also found that faults occurred indicating there were memory errors.However, the specific memory errors observed will not cause the device to reset and operate in safety mode.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Normal operation was observed.The results of the device analysis confirm the clinical observation, but the root cause of the failure could not be confirmed.

Event Description

It was reported that a remote monitoring transmission was received by the healthcare provider (hcp) which indicated that this cardiac resynchronization therapy pacemaker (crt-p) device had reverted to safety mode with limited critical therapy still available.Boston scientific technical services (ts) discussed with the hcp what safety mode means, indicated that the device needs to be replaced and suggested talking with the patient about any exposure to radiation or other things that may have caused the device to revert to safety mode.The hcp noted that the patient is pace therapy dependent and indicated that they will review this issue with the physician.The device was subsequently explanted and replaced three (3) days later.As part of this replacement procedure, the device was interrogated, and the safety mode codes that were observed all indicate a device memory issue.No additional adverse patient effects were reported.The device was returned to boston scientific and device analysis was completed.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10638263
• MDR Text Key: 210159223
• Report Number: 2124215-2020-19386
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/27/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 03/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR