MAUDE Adverse Event Report: GREATBATCH MEDICAL BIPOLAR LEAD ADAPTER

Model Number 501206

Device Problem Low impedance (2285)

Patient Problem Therapeutic Response, Increased (2272)

Event Date 07/17/2015

Event Type  malfunction  

Event Description

Information was received that adapters were being used with another company's unipolar right ventricular (rv) and right atrial (ra) leads of this cardiac resynchronization therapy (crt) system.This adapter was used with the chronic rv lead.The day post implant the pacing lead impedances were normal and then there was an abrupt drop and the lead impedances were noted to be less than 200 ohms.Potential reasons for the observation were discussed.The patient was pacemaker dependent and surgical intervention was performed.The adapters were explanted and the rv and ra leads were surgically abandoned.New rv and ra leads were implanted and the generator remains in service.Further information was provided that at the lead replacement procedure the ra lead was evaluated with the pacing system analyzer (psa) and the impedances were 400 ohms.The adapter was removed and the lead fell apart.The rv lead was re-evaluated with the psa since the patient was pacemaker dependent.The adapters were discarded by the hospital staff and are not expected to be returned.No additional adverse patient effects were reported.This is the same event as reported in mdr 2183787-2015-00098.

• Brand Name: BIPOLAR LEAD ADAPTER
• Type of Device: BIPOLAR LEAD ADAPTER
• 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: 5059316
• MDR Text Key: 25111685
• Report Number: 2183787-2015-00099
• Device Sequence Number: 1
• Product Code: DTD
• 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: Nurse
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: 501206
• Device Catalogue Number: BSC6986
• Device Lot Number: W3007974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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