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

Model Number 511214

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/07/2018

Event Type  malfunction  

Event Description

As reported: the epicardial lead with the adapter was not functioning and the physician opted to place a transvenous lead.No additional information was provided.This is a similar event as mdr 2183787-2018-00083.

• Brand Name: LEAD ADAPTOR
• Type of Device: BIPOLAR LEAD ADAPTOR
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• Manufacturer Contact: rhonda stager ; 2300 berkshire lane; minneapolis, MN 55441 ; 7639518376
• MDR Report Key: 7985172
• MDR Text Key: 124363032
• Report Number: 2183787-2018-00084
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00821329900280
• UDI-Public: 00821329900280
• 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: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: 511214
• Device Lot Number: W4113507
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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