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

Lot Number C4-14020

Device Problem Low impedance (2285)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, impedance with previous scan was 350-373 ohms and with oscor m/is-10 adaptor impedance is 150-171 ohms.Adaptor was implanted with rv lead.New rv lead was implanted to resolve product issue.Adaptor remains in use.There was no patient complication or injury reported.No additional information is available.

Manufacturer Narrative

The adaptor was used for treatment and is still implanted for approximately 28 days since the (b)(6) 2019 event date.It will not be returned for analysis, therefore, the clinical observation could not be confirmed.However, the information provided indicates there is an issue with impedance for the oscor adaptor.The oscor adaptor is only one part of the entire pacing system.The impedance that was reported likely includes the oscor adaptor and the pacing lead.Typically the impedance is slightly higher immediately following implant of the pacing lead.Then decreases after the lead has been implanted for a short period of time.This decrease in impedance has nothing to do with the oscor adaptor and is more related to the fixation of the pacing lead.There was no device performance related issue reported.No additional information is available.Per procedure check electrical resistance by using a multimeter.Follow "electrical resistance criteria - adaptors" document.Record the measurements on the work order.The instructions for use (ifu) informs the user: 6.Directions for use - 1.Insert the connector pin of the lead into the receptacle portion of the adaptor/extension until the connector pin is completely inserted into the metal portion of the sleeve of the receptacle.2.Using a screwdriver, tighten the screw by turning it clockwise until resistance is met.3.Pull gently on the adaptor/extension to confirm that the connection is secure.4.Check the adapted/extended lead for electrical continuity by rechecking the threshold values.5.Secure the silicone sleeve of the adaptor by using a non-absorbable suture tie in the groove provided, at the distal end of the adaptor/extension.6.Fill the screw hole with silicone medical adhesive (not included in this package).7.Product awareness: the adaptors/extensions are implanted in the extremely hostile environment of the human body.Because the adaptors/extensions are very small in diameter and must be very flexible, it inevitably reduces their potential performance and longevity.Adaptors/extensions 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/extension 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/extensions may be damaged by improper handling, use, placement or other intervening facts.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.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
• MDR Report Key: 8836873
• MDR Text Key: 185961659
• Report Number: 1035166-2019-00061
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• PMA/PMN Number: K925168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: C4-14020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention