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

Model Number 501206

Device Problems Failure to Capture (1081); High impedance (1291)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/15/2019

Event Type  malfunction  

Event Description

As reported high impedance and non capture were exhibited when the lead extenders were attached.The lead was capped and the adapters were explanted were retained at the hospital and will not be returned.This is a similar events mdr 2183787-2019-00046 and mdr 2183787-2019-00047.

• Brand Name: LEAD ADAPTOR
• Type of Device: BIPOLAR LEAD ADAPTOR
• Manufacturer (Section D): GREATBATCH MEDICAL; 2360 berkshire lane; plymouth MN 55441
• Manufacturer Contact: rhonda stager ; 2360 berkshire lane; plymouth, MN 55441 ; 7639518376
• MDR Report Key: 8663581
• MDR Text Key: 146832574
• Report Number: 2183787-2019-00048
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: 501206
• Device Lot Number: W4336255
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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