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

Model Number C/IS-10 SS2

Device Problems High impedance (1291); Loose or Intermittent Connection (1371)

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

Event Date 06/09/2021

Event Type  Injury  

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 was focused on a review of product documentation.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.Final inspection, labeling /packaging of all products: inspection of the packaged product will be performed at a distance of approximately 18 inches with corrected vision/unaided eye.Tyvek lid/tray and breather bag / pouch - visually inspect the sealed areas are continuous around entire perimeter of tray.Voids, breaks, and or bubbles along the seal are not allowed.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.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.

Event Description

It was reported that when the data of the lead itself was measured as it was, the pacing threshold was 2.8v x 0.5ms and the resistance was 900?, but when it was connected to the 6161 adapter and measured, the pacing threshold was over 5.0v and the resistance was over 3000?.Additionally, the customer stated that they were unable to determine the cause of the high impedances >3000 ohms and high thresholds.When the lead was tested by itself, measurements were normal, but when connected to the adapter, measurements were high out of range.It was suspected there was a poor connection of the adapter and incomplete fracture of the lead but could not be confirmed.

Manufacturer Narrative

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: 12159451
• MDR Text Key: 261267037
• Report Number: 1035166-2021-00063
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00885672008277
• UDI-Public: 00885672008277
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: C/IS-10 SS2
• Device Catalogue Number: C/IS-10 SS2
• Device Lot Number: C1-17601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR