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

Model Number	BIS/IS-15
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Low impedance (2285); High Capture Threshold (3266)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	11/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.
Event or Problem 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).
Additional 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
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6275604
• Report Number: 1035166-2017-00002
• Device Sequence Number: 13675313
• Product Code: DTD
• UDI-Device Identifier: 00836559002680
• UDI-Public: 00836559002680
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K925168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 05/16/2018
• 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: Hospitalization; Life Threatening; Required Intervention