MAUDE Adverse Event Report: OSCOR INC. LEAD ADAPTOR; PACEMAKER LEAD ADAPTOR

Model Number	BIS/BIS-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) system was explanted due to an infection.The organism was identified as staphylococcus epidermidis.A new system will be implanted at a later date.No further patient complications have been reported as a result of this event.There was no specific issue to the bis/ bis adaptor reported.
Additional Manufacturer Narrative
The adaptor used in treatment.The device was not returned for analysis.The adaptor was in service for approximately 1days before being explanted on (b)(6) 2020.The investigation will focus on a review of product documentation.The device history records were reviewed to confirm that the adaptor passed all applicable in process and final inspections.Infection is a recognized clinical event referenced in the device's labeling and/or reported in the medical literature.There was no issue reported specific to the bis/bis adaptor nor our device failed to meet its performance specifications or caused or contributed to the infection.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.No further follow-up is required.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.
Additional Manufacturer Narrative
Corrected data: d7: the adaptor was in service for approximately 2 month before being explanted on (b)(6) 2020.As per ifu: infection is one of the possible complications.As with the introduction of any foreign object into the body, an infection might result.Removal of the device may be required.Intermittent or continuous loss of pacing and sensing may be caused by the device's poor connection, or disconnection, or damage.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.No further follow-up is required.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: LEAD ADAPTOR
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor, fl
• MDR Report Key: 10166992
• Report Number: 1035166-2020-00038
• Device Sequence Number: 19673227
• Product Code: DTD
• UDI-Device Identifier: 00885672008369
• UDI-Public: 00885672008369
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K010787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2020

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: BIS/BIS-40
• Device Catalogue Number: BIS/BIS-40
• Device Lot Number: OR-04921
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020; 09/03/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/25/2020; 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention