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

Model Number V183

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

Patient Problems Muscle Stimulation (1412); Device Overstimulation of Tissue (1991); No Code Available (3191)

Event Date 04/11/2020

Event Type  Injury  

Manufacturer Narrative

Following completion of laboratory analysis, this event will be further updated.(b)(4).

Event Description

It was reported that this device was operating in safety mode and resulting in unipolar pacing at high outputs.Due to high outputs, the patient has reported feeling pocket stimulation.The patient does have underlying rhythm thus no resulting adverse patient effects have been reported.The device has since been explanted, replaced and returned for a full post market analysis so as to determine the cause of this clinical finding.

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, which resulted in software resets that were performed in an attempt to correct the error.These resets then caused the device to enter safety mode.The battery was removed and detailed analysis was able to confirm the cell had a high internal impedance.The high internal impedance resulted in the software resets, reversion to safety mode operation and the reported clinical observations.

Event Description

It was reported that this device was operating in safety mode and resulting in unipolar pacing at high outputs.Due to high outputs, the patient has reported feeling pocket stimulation.The patient does have underlying rhythm thus no resulting adverse patient effects have been reported.The device has since been explanted, replaced and returned for a full post market analysis so as to determine the cause of this clinical finding.

• 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
• MDR Report Key: 11227787
• MDR Text Key: 241236521
• Report Number: 2124215-2020-28996
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2015
• Device Model Number: V183
• Device Catalogue Number: V183
• Device Lot Number: 100236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2020
• Date Manufacturer Received: 04/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR