MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number V183

Device Problems Premature Discharge of Battery (1057); Pacing Problem (1439); Premature Elective Replacement Indicator (1483)

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

Event Date 04/11/2023

Event Type  Injury  

Event Description

It was reported that this device was explanted and replaced for reaching elective replacement indicator.The device went from pacing to no pacing with intrinsic ventricular rhythm of 35 beats per minute when the device was interrogated in the operating room just prior to replacement.It was noted that the hospital staff suspected that the device had been at end of life for a while since there was no prior patient history provided, and the patient was not followed by the clinic.No additional adverse patient effects were reported.It is unknown at this time if this device is available for return.A good faith effort was submitted to the field to obtain product return.

Event Description

It was reported that this device was explanted and replaced for reaching elective replacement indicator.The device went from pacing to no pacing with intrinsic ventricular rhythm of 35 beats per minute when the device was interrogated in the operating room just prior to replacement.It was noted that the hospital staff suspected that the device had been at end of life for a while since there was no prior patient history provided, and the patient was not followed by the clinic.No additional adverse patient effects were reported.Additional information: several requests were submitted to the field to obtain product return.A response was provided from the field representative indicating that this device would be returned; however, this device has not been received.

Manufacturer Narrative

This device has not been returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: INVIVE
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 16861248
• MDR Text Key: 314470649
• Report Number: 2124215-2023-21468
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/04/2015
• Device Model Number: V183
• Device Catalogue Number: V183
• Device Lot Number: 100581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2013
• 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): Required Intervention; Hospitalization
• Patient Age: 30 YR
• Patient Sex: Male