MAUDE Adverse Event Report: MEDTRONIC ADAPTA DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ADDR01

Device Problem Under-Sensing (1661)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This device was implanted on (b)(6) 2008 and was explanted on (b)(6) 2012 due to under sensing and connection issues.The physician was dr.(b)(6) at (b)(6) medical center in (b)(6).Follow this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ADAPTA DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17522095
• MDR Text Key: 321423107
• Report Number: MW5129043
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 12/21/2012

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: ADDR01
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1