MAUDE Adverse Event Report: BOSTON SCIENTIFIC RV LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 0292-59

Device Problems Device Sensing Problem (2917); Protective Measures Problem (3015)

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

Event Type  malfunction  

Event Description

Alert for rv impedance measurement of 0 ohms.Hcp stated pt was in the hospital on the same day for a surgery or pr (b)(6) 2023 09:00:03 *rv lead integrity warning: sensing integrity counter >= 30 in 3 days.Rv lead impedance variation in last 60 days reviewed battery and lead measurements, there have been 574 short v-v's since (b)(6) 2023.Reviewed lead trends, the bipolar lead trend shows spike of 836 ohms on (b)(6) 2023 transmission.Reviewed lead details with caller, this lead is a bsci integrated bipolar rv lead, please contact bsci technical services about lead behaviour.Also, bringing the patient in for in office interrogation to reproduce lead noise in office with isometrics and pocket manipulation would be recommended.Ocedure.Unknown what pt had done.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17488164
• MDR Text Key: 320693378
• Report Number: MW5120887
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2023

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?: No
• Device Model Number: 0292-59
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1