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

Model Number 501206

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2017

Event Type  malfunction  

Event 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
• 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
• MDR Report Key: 7086153
• MDR Text Key: 94141917
• Report Number: 2183787-2017-00126
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00821329900266
• UDI-Public: 00821329900266
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: 501206
• Device Lot Number: W3448829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2005
• 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