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

Model Number BIS/BIS-40

Device Problem Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2022

Event Type  malfunction  

Event Description

It was reported that during the implant procedure the extender was connected to existing lead and then connected to the implantable pulse generator (ipg) and low impedance was noted 114 ohms.The physician proceeded to test the original lead after disconnecting the extender and it was within normal limits.The extender was attempted implant, not used and was replaced with another extender.No patient complications have been reported as a result of this event.No additional information is available.

Manufacturer Narrative

Our investigation is still in progress, follow up report will be submitted if we find any further additional information.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.

Manufacturer Narrative

The adaptor was never implanted and it was attempted use.The device was used for treatment.The investigation was focused on review of product documentation.The device was not returned for analysis, therefore, the clinical observation could not be confirmed the device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.However, the following controls are in place to mitigate the reported product issue.Per procedure bipolar lead adaptor/extension final inspection electrical inspection devices are inspected 100% as follows: check electrical resistance by using multimeter.Extension bis/bis: attach the red cable to the connector pin and black cable to the trokar needle.Insert trokar needle straight on the screw head through the seal of the connector pin receptacle on both legs and check for resistance.Insert trokar needle into the other screw for connector hull receptacle to assure that there is no electrical connection/short.Attach red cable to the connector hull and follow the same method as above for the connector hull receptacles on both legs.The instructions for use (ifu) in forms user, bis/bis adaptor: the adaptors are implanted in the extremely hostile environment of the human body.Because the adaptors are very small in diameter and must be very flexible, it inevitably reduces their potential performance and longevity.Adaptors may fail to function for a variety of causes, including medical complications, body rejection phenomenon, allergic reaction, fibrotic tissue problem, or a failure of adaptor by damage, fracture, or by breach of their insulation.Despite of all due care in design, component quality, manufacture and testing prior to sale, adaptors may be damaged by improper handling, use, placement or other intervening facts.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.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
• Type of Device: 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: daniel naut ; 3816 desoto blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 14675523
• MDR Text Key: 293949159
• Report Number: 1035166-2022-00073
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00885672008369
• UDI-Public: 00885672008369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010787
• 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,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIS/BIS-40
• Device Catalogue Number: BIS/BIS-40
• Device Lot Number: C4-15328
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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