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

Model Number	501206
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
As reported the patient required a crtp system to be moved from (l) pectoral region to (r) pectoral region due to patient requiring radiotherapy on their (l) side.This involved tunnelling leads across the chest.The lv lead was long enough but the atrial and rv were too short.After discussion with the doctor, it was decided to attach lead adaptors to each of these 2 leads to provide enough length to take them from (l) to (r).When attempting to remove the hex wrench from the set screw of the adapter for the atrial lead, the hex wrench broke.The doctor tried to cut the hex wrench remnants with scissors but in attempting to do this the proximal end of the lead snapped off.A new atrial lead was implanted.

• Brand Name: BIPOLAR ADAPTOR
• Common Device Name: BIPOLAR LEAD ADAPTOR
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 7086153
• Report Number: 2183787-2017-00126
• Device Sequence Number: 1450879
• Product Code: DTD
• UDI-Device Identifier: 00821329900266
• UDI-Public: 00821329900266
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K870562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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: 05/01/2019
• Device Model Number: 501206
• Device Lot Number: W3448829
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1