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

Model Number	501206
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Event or Problem 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 2183787-2019-00048.

• Brand Name: LEAD ADAPTOR
• Common Device Name: BIPOLAR LEAD ADAPTOR
• Manufacturer (Section D): GREATBATCH MEDICAL; 2360 berkshire lane; plymouth MN 55441
• MDR Report Key: 8663585
• Report Number: 2183787-2019-00047
• Device Sequence Number: 2182874
• Product Code: DTD
• UDI-Device Identifier: 00821329900266
• UDI-Public: 00821329900266
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K870562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 05/01/2021
• Device Model Number: 501206
• Device Lot Number: W4336255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1