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

Model Number	501214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The returned device was not evaluated.The device went through at least one decontamination procedure using a high-level disinfectant (i.E.Cidex opa) in accordance with its manufacturer's recommendations and therefore, most if not all microorganisms were eliminated from the device.Since infection results from the presence of microorganisms, additional testing to attempt to identify the source of infection is not feasible.
Event or Problem Description
It was reported that lead adapter was explanted due to infection/sepsis.Left surgical site infected from where ra and lv leads were tunneled to patient's abdomen.Leads and adapters were extracted and ports were plugged on the device.Pt does still have an rv lead that was tunneled from the right shoulder area.Pg and rv are not infected.

• Brand Name: LEAD ADAPTOR
• Common Device Name: BIPOLAR LEAD ADAPTOR
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; plymouth MN 55441
• MDR Report Key: 8335969
• Report Number: 2183787-2019-00015
• Device Sequence Number: 14033996
• Product Code: DTD
• UDI-Device Identifier: 00821329900280
• UDI-Public: 00821329900280
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: 501214
• Device Lot Number: W3959484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention