MAUDE Adverse Event Report: GREATBATCH MEDICAL MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 35CM; BIPOLAR EPICARDIAL LEAD

Model Number 511211

Device Problem High impedance (1291)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/27/2015

Event Type  malfunction  

Event Description

Information was received that the left ventricular (lv) lead displayed increased pacing impedance measurements greater than 2,000 ohms.A revision procedure was returned and device was explanted.The lv lead was surgically abandoned.No adverse pt effects were reported during the procedure.

• Brand Name: MYOPORE SUTURELESS MYOCARDIAL PACING LEAD 35CM
• Type of Device: BIPOLAR EPICARDIAL LEAD
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane north; minneapolis MN 55441
• Manufacturer Contact: kristi fox ; 2300 berkshire lane north; minneapolis, MN 55441 ; 7639518181
• MDR Report Key: 4742691
• MDR Text Key: 5887040
• Report Number: 2183787-2015-00044
• Device Sequence Number: 1
• Product Code: LDF
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: 511211
• Device Catalogue Number: BSC4046
• Device Lot Number: W2567828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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