MAUDE Adverse Event Report: SORIN DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Model Number 2CR-6

Device Problem Low impedance (2285)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/19/2012

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2011 and was abandoned on (b)(6) 2012 due to impedance less than 200 ohms.The physician was dr.(b)(6) at (b)(6) center in (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Type of Device: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Manufacturer (Section D): SORIN
• MDR Report Key: 17531670
• MDR Text Key: 321251049
• Report Number: MW5138583
• Device Sequence Number: 1
• Product Code: MRM
• 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: 07/13/2012

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: 2CR-6
• Patient Sequence Number: 1