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

Model Number K274

Device Problems Premature Discharge of Battery (1057); Impedance Problem (2950)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

Pacemaker is under bsc (boston scientific corporation) advisory for high battery impedance; per bsc tech support, issue most likely to happen when battery reaches ~4 years longevity.Patient seen in office with estimated ~4 years remaining battery longevity.Discussion with provider and patient and opted to do prophylactic pacemaker generator change.Waiting to be scheduled.

• Brand Name: VITALIO
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15601947
• MDR Text Key: 301736617
• Report Number: 15601947
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/05/2022,10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: K274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2022
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 10/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male