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

Model Number V173

Device Problems Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Muscle Stimulation (1412); Device Overstimulation of Tissue (1991)

Event Date 12/25/2020

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested from the field.If additional information is received, this report will be updated.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited an alert and was found to be operating in safety mode.The patient was subsequently experiencing symptoms associated with diaphragmatic stimulation.Technical services (ts) recommended device replacement.The device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited an alert and was found to be operating in safety mode.The patient was subsequently experiencing symptoms associated with diaphragmatic stimulation.Technical services (ts) recommended device replacement.The device remains in service.No adverse patient effects were reported.Additional information was received which reported that this device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

It was noted that the device was not available for return.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited an alert and was found to be operating in safety mode.The patient was subsequently experiencing symptoms associated with diaphragmatic stimulation.Technical services (ts) recommended device replacement.The device remains in service.No adverse patient effects were reported.Additional information was received which reported that this device was explanted and replaced.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 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.It was noted that the device was not available for return.If information is provided in the future, a supplemental report will be issued.

• 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: 11211779
• MDR Text Key: 228174514
• Report Number: 2124215-2021-01242
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2021

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: 03/25/2016
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 106154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 12/25/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/28/2021; 04/16/2021
• Supplement Dates FDA Received: 02/21/2021; 06/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 17 YR