MAUDE Adverse Event Report: GREATBATCH MEDICAL LEAD ADAPTOR; BIPOLAR EPICARDIAL LEAD ADAPTER

Model Number 501206

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/31/2020

Event Type  malfunction  

Event Description

It was reported that ra lead and adapter were capped/abandoned for an unknown the reason.Attempts for more information were unsuccessful.

• Brand Name: LEAD ADAPTOR
• Type of Device: BIPOLAR EPICARDIAL LEAD ADAPTER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; plymouth, mn
• Manufacturer Contact: rhonda stager ; 2300 berkshire lane; plymouth, mn ; 9518376
• MDR Report Key: 9785345
• MDR Text Key: 182309434
• Report Number: 2183787-2020-00023
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 501206
• Device Catalogue Number: 6986
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1