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

Model Number V173

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

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 healthcare provider (hcp) was unable to interrogate this cardiac resynchronization therapy pacemaker (crt-p) device using a consult communicator.Boston scientific technical services (ts) confirmed that this is crt-p device is compatible with a consult communicator and indicated the issue could be related to the device battery being too low to complete an interrogation or the device could be in safety mode.Ts provided guidance to move the communicator wand around and the hcp stated they have tried this several times without success.The hcp requested to have the local boston scientific representative paged to help troubleshoot the issue.Subsequently, the boston scientific representative successfully interrogated the crt-p device with a programmer and found it was in safety mode with limited critical therapy still available.Ts recommended replacing the device and discussed the associated considerations and urgency, specifically if the patient is pace therapy dependent due to the possibility of oversensing and pacing inhibition occurring while the device is operating with safety mode settings.The device was subsequently explanted and replaced later the same day.No additional adverse patient effects were reported.

• Brand Name: INVIVE
• Type of Device: IMPLATABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12644204
• MDR Text Key: 276893794
• Report Number: 2124215-2021-29418
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536632
• UDI-Public: 00802526536632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 103896
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR