MAUDE Adverse Event Report: MEDTRONIC, INC. ADAPTA; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number ADDR01

Device Problems Off-Label Use (1494); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

The medtronic pacemaker and rv lead were removed for an icd bi-v upgrade.The new dual coil rv icd lead that was implanted was removed due to failed dft's.The single coil rv icd lead was removed due to the wrong lead being handed off and not realized until insertion.

• Brand Name: ADAPTA
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 4951878
• MDR Text Key: 20726067
• Report Number: 4951878
• Device Sequence Number: 1
• Product Code: NVZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/25/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: ADDR01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2015
• Patient Sequence Number: 1