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

Model Number BIS/IS-15

Device Problems Electrical /Electronic Property Problem (1198); Low impedance (2285); High Capture Threshold (3266)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 11/15/2016

Event Type  Injury  

Manufacturer Narrative

Conclusion not yet available, evaluation in process.

Event Description

It was reported that an electrical short in the lead adaptor was causing diaphragmatic and nerve stimulation from the left ventricular (lv) lead.High thresholds and low impedance were also observed.The adaptor was removed.No further patient complications have been reported as a result of this event.Hospital: (b)(6).

Manufacturer Narrative

A review of device history record (dhr) was conducted and there were no manufacturing rejects or anomalies of this type recorded in the dhr.The device passed all in-process and qa final inspection steps before shipping to the customer.A complaint review of the reported lot found no additional reports involving this lot number.Although requested, the device was not returned for analysis.As a result, the allegations against this lead cannot be confirmed and a root cause of the failure could not be determined.Per procedure unipolar and bifurcated bipolar lead adaptors/extensions and lead extension with universal coupler final inspection: the setscrew is checked by qa 100 percent both visually and with a torque wrench to ensure smooth functionality.The electrical values are checked by qa 100 percent as well.Per instructions for use (ifu) regarding product awareness: 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.The event will be re-evaluated if additional information becomes available.Based the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.Oscor will continue to monitor this event type.

• Brand Name: BIPOLAR LEAD ADAPTOR
• Type of Device: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: dorit segal ; 3816 desoto blvd; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 6275604
• MDR Text Key: 65689151
• Report Number: 1035166-2017-00002
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00836559002680
• UDI-Public: 00836559002680
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/01/2019
• Device Model Number: BIS/IS-15
• Device Catalogue Number: BIS/IS-15
• Device Lot Number: C4-12952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention