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 Arrhythmia (1721); Unspecified Heart Problem (4454)

Event Date 02/07/2021

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode and the patient is feeling palpitations in her chest.Boston scientific technical services (ts)recommended to follow-up with the patient as soon as possible if the patient is dependent or intermittent and recommended to send the device back for analysis once explanted.The field representative called back and the patient is scheduled for a device replacement.Subsequently, this crt-p was explanted and replaced successfully.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.Review of device memory identified an error that resulted in software resets performed in an attempt to correct an identified inconsistency.The battery was removed and detailed analysis was able to confirm the cell had a high internal resistance.The high internal resistance resulted in the software resets, reversion to safety mode operation and the patient feeling palpitations.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode and the patient is feeling palpitations in her chest.Boston scientific technical services (ts)recommended to follow-up with the patient as soon as possible if the patient is dependent or intermittent and recommended to send the device back for analysis once explanted.The field representative called back and the patient is scheduled for a device replacement.Subsequently, this crt-p was explanted and replaced successfully.No additional adverse patient effects were reported.

• 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: 11356385
• MDR Text Key: 232839425
• Report Number: 2124215-2021-03689
• 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
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2015
• Device Model Number: V173
• Device Catalogue Number: V173
• Device Lot Number: 102933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR