MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 4136

Patient Problem Shock from Patient Lead(s) (3162)

Event Type  Injury  

Event Description

Inappropriate therapy/shock due to over sensing/noise on rv lead.Rv lead integrity alert triggered for two high rate ns events and 240 short v-v interval events.Clinician confirmed that the patient had an avr performed on (b)(6) 2023 and stated that it was likely the patient was in the operating room at the time.Rv lead trends appear to be stable and no oversensing noted on current egm and no subsequent episodes detected.Atrial threshold last measured 1.5 v at 0.40 ms.See atrial threshold trends for possible increase in measurement.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5146716.

• Brand Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17904447
• MDR Text Key: 325471936
• Report Number: MW5146717
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4136
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention