MAUDE Adverse Event Report: GREATBATCH MEDICAL 54 CM BIPOLAR LEAD

Model Number 511212

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 05/27/2014

Event Type  malfunction  

Event Description

A device registration form was received stating that this lead was capped.The reason for the lead being capped was listed as "other".

Manufacturer Narrative

Na.

• Brand Name: 54 CM BIPOLAR LEAD
• Type of Device: BIPOLAR LEAD
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane north; minneapolis MN 55441
• Manufacturer Contact: kristi fox, senior specialist ; 2300 berkshire lane north; minneapolis, MN 55441 ; 7639518181
• MDR Report Key: 4004834
• MDR Text Key: 4690825
• Report Number: 2183787-2014-00089
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2011
• Device Model Number: 511212
• Device Lot Number: W56252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2008
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR