MAUDE Adverse Event Report: OSCOR INC. LEAD ADAPTOR; PACEMAKER LEAD ADAPTOR, PRODUCT CODE: DTD

Model Number BIS/BIS-40

Device Problems High impedance (1291); Over-Sensing (1438); Under-Sensing (1661); Ambient Noise Problem (2877); Noise, Audible (3273)

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

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

Our investigation is still in progress.

Event Description

It was reported that the right atrial (ra) lead and extender lead exhibited noise with movement, high impedance and undersensing.Both ra lead and extender lead remains in use.Patient is a (b)(6) female.No patient complications have been reported as a result of this event.On 2020-10-28 it was further reported that the ra lead was capped and replaced.

Manufacturer Narrative

The device was in use for treatment.The device was implanted on (b)(6) 2019.The device was in service for approximately 1 year, 8 months before being abandoned / capped on (b)(6) ; therefore, the investigation will focus on a review of product documentation.The device was not returned for analysis, therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.However, following controls are in place to mitigate the reported product issue.Per procedure (bipolar lead adaptors/extensions final inspection) 10.Set screws and transport protection pin inspection (visual inspection) 10.1 screw seals (two knobs on the receptacle) are cut approximately in the center and are shaped as a trokar cut.They will open during the insertion of the screwdriver and will reseal after removing the screwdriver.Insert the appropriate "test" connector into the receptacle and tighten the set screw using the 14 in/oz torque wrench.The torque wrench must click which verifies the set screw was tightened correctly.10.2 adaptor 2xbis/bis: before inserting the screwdriver, use tweezers to verify trokar cut is uniform, if not, contact engineering.Use a small amount of alcohol with z-foam on the screw seals for easy insertion of screwdriver and to prevent from breaking the seals.Insert very carefully a screwdriver straight all the way down through the opening of the connector pin receptacle screw seal to sit on the screw head.If needed, manipulate the screwdriver lightly to sit on the screw head.Turn the screwdriver slowly clockwise until resistance is felt.Slightly turn the screwdriver counter-clockwise.Repeat with the second set screw.Remove the screwdriver straight up and pull gently on the protection pin to assure that it can be easily extracted and reinsert it completely.After the screwdriver is pulled out, verify under 10x microscope that the seals are closed and not damaged.10.3 extension bis/bis: use the same method as above for a single receptacle.Per procedure (ifu): 1.Do not remove the connector of the lead to be adapted.2.Insert a torque wrench through the screw seals of the bipolar is-1 receptacle and turn both screws 1/4 - 1/2 turn (no more than 1/2 turn) counterclockwise and remove the white safety transportation pin "a" 3.Insert the lead connector completely into the receptacle part of the extension.Confirm that the connector pin is visible in the hole of the receptacle.4.Tighten both screws "c" of the receptacle with the screwdriver.A ligature may be placed in the groove of the receptacle's end to prevent body fluids from ingressing.5.After removing the screwdriver, use silicone medical adhesive on the screw seals for protection against body fluid ingression.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.

Manufacturer Narrative

Corrections made to b1, h1, h2, h6: corrected b1; as the event is serious and a malfunction.Corrected h1 to include serious.Corrected code for noise at h6.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 following sections were updated in follow-up 3.Correction to event information: removing oversensing and adding undersensing.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, PRODUCT CODE: DTD
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 10800412
• MDR Text Key: 215619590
• Report Number: 1035166-0200-00069
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00885672008369
• UDI-Public: 00885672008369
• Combination Product (y/n): N
• PMA/PMN Number: K010787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: BIS/BIS-40
• Device Catalogue Number: BIS/BIS-40
• Device Lot Number: C4-13516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR