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

Model Number	C/IS-10 SS2
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A preliminary review showed there were no manufacturing rejects or anomalies of this event type recorded in the device history record.Conclusion not yet available as the investigation is on-going.
Event or Problem Description
Reporter received a call on (b)(6) 2018, that indicated the male patient, (b)(6) was in clinic and brought their communicator, which displayed a red call doctor icon.Patient services assisted the health care professional with successfully connecting the communicator to the server.A red alert posted for out of range rv pacing impedance measurements.Additional information has been requested however at the time of this report no further information is available regarding the product nor the incident.
Additional Manufacturer Narrative
The device was in use for treatment.The device was not returned for analysis.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.The investigation will focus on a review of product documentation.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity and no new failure mode identified.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type.Per procedure unipolar and bifurcated bipolar lead adaptors/extensions and lead extension with universal coupler final inspection: all products must meet pre-determined specifications in each step of the inspection procedure including crimp, laser weld, inner coil to connector pin and inner pu tubing positioning, physical / mechanical inspection includes length measurements, insertion/ withdrawal force test on is-1 connector, pull test when applicable, dimensional and connector measurements.Applicable electrical, cosmetic and documentation reviews are completed.Per instructions for use (ifu) : possible complications: as with the introduction of any foreign object into the body, an infection might result.Removal of the device may be required.Intermittent or continuous loss of pacing and sensing may be caused by the device's poor connection, disconnection, or damage.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
• Common Device Name: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 7439537
• Report Number: 1035166-2018-00031
• Device Sequence Number: 13726747
• Product Code: DTD
• UDI-Device Identifier: 00885672102739
• UDI-Public: 00885672102739
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/02/2018
• Device Model Number: C/IS-10 SS2
• Device Catalogue Number: C/IS-10 SS2
• Device Lot Number: C1-09755
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1