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

Model Number 4037

Device Problem Failure to Capture (1081)

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

Event Date 09/26/2022

Event Type  malfunction  

Event Description

It was reported that lead was not able to capture.There was no patient side effect reported and lead remains implanted.No additional information is available.

Manufacturer Narrative

Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.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.

Manufacturer Narrative

The device remains in service for approximately 19 years, 7 months since the event date (b)(6) 2022.Qa is unable to review the device history records for this lead model as it is beyond oscor's record retention period, however, inspection procedures require oscor products to pass all in-process and qa final inspection before shipping to the customer.The lead was in use for treatment.The lead was not returned for analysis, as it remains implanted.Therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.However, following controls are in place to mitigate the reported product issue.A review of the qa (permanent pacing lead final inspection) procedure indicates that the lead is checked 100% for electrical function.The procedure includes "acceptance criteria all products must meet pre-determined specifications in each step of this procedure.If product does not comply with specifications, it must be rejected.An unusual or questionable or often repeating defect must be reported to qa management immediately." electrical function: electrical resistance has to be checked with a multimeter.Record ohms readings on work order.All tubing will be inspected according to the procedure # 9b-50-001x-e, "criteria/inspection of polyurethane and silicone tubing".The electrodes should be clean and have no adhesive or other residue.Electrodes should be smooth and free of scratches.The instructions for use (ifu), permanent implantable pacing leads, provides information on possible complications: with the use of endocardial leads, complications might occur during implantation, explantation or at any time postoperatively and may require non-invasive or invasive techniques for management, as determined by the clinical judgment of the physician.Intermittent or continuous loss of pacing or sensing can be caused by displacement of the electrode, unsatisfactory electrode position, breakage of the conductor or its insulation, an increase in thresholds, or poor electrical connection to the pulse generator.Based on the investigation, a capa is not required.This lead is no longer manufactured by oscor.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: ZY PERMANENT PACING LEAD
• Type of Device: PACEMAKER LEAD ADAPTOR
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: daniel naut ; 3816 desoto blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 15685894
• MDR Text Key: 307168818
• Report Number: 1035166-2022-00115
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4037
• Device Catalogue Number: 4037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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