MAUDE Adverse Event Report: OSCOR INC. BLV/BIS-10; PACEMAKER LEAD ADAPTOR

Model Number	BLV/BIS-10
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/15/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient died due to acute respiratory failure, covid-19 and congestive heart failure.Patient death was not related to device malfunction and there was no device malfunction reported.No additional information is available.
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
Additional Manufacturer Narrative
There was no issue with adaptor blv/bis-10 reported.Its unknown when the adaptor is implanted.Customer did not provided the current status of the adaptor or correct implant date.The investigation was focused on a review of product documentation.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspection.The device was not returned for analysis.There was no specific performance related failure reported by the user.No further investigation is required.No further follow-up is required.No corrective or preventive action resulted after investigation of this event.The event will be reevaluated if additional information becomes available.Oscor will continue to monitor this event type.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

• Brand Name: BLV/BIS-10
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer Contact: doug myers ; 3816 desoto blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 14194555
• Report Number: 1035166-2022-00061
• Device Sequence Number: 4297532
• Product Code: DTD
• UDI-Device Identifier: 00836559006411
• UDI-Public: 00836559006411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K925168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 08/01/2008
• Device Model Number: BLV/BIS-10
• Device Catalogue Number: BLV/BIS-10
• Device Lot Number: C2-07839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown