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

Model Number	511214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: BIPOLAR LEAD ADAPTOR
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 7985172
• Report Number: 2183787-2018-00084
• Device Sequence Number: 1395870
• Product Code: DTD
• UDI-Device Identifier: 00821329900280
• UDI-Public: 00821329900280
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K870562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: 511214
• Device Lot Number: W4113507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1