MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 0235 (ENDOTAK RELIANCE)

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Lia sounded several times due to high sic and nsvr episodes.Rv lead model might be 0295, not 0235.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ENDOTAK RELIANCE
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): CPI - DEL CARIBE
• MDR Report Key: 17531026
• MDR Text Key: 321428695
• Report Number: MW5137942
• 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: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 0235 (ENDOTAK RELIANCE)
• Patient Sequence Number: 1