MAUDE Adverse Event Report: BIOTRONIK RV LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number BLOTRONLK LLNOX SMART SD 65/18

Device Problems Connection Problem (2900); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The device had a connection issue with the rv lead.There has been a rv integrity alert today because of short w-lntervals and several ns-vt which first occurred yesterday.The impedances are within normal parameters.(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): BIOTRONIK
• MDR Report Key: 17524768
• MDR Text Key: 321133427
• Report Number: MW5131712
• 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: 03/02/2022

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: BLOTRONLK LLNOX SMART SD 65/18
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1