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

Model Number	C/IS-10 SS2
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2014
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reopened this complaint from a vintage system; reported event date is 2014-10-14.The customer received information that this patient exhibited some myopotentials in both the right atrial (ra) lead and right ventricular (rv) leads.The ra lead is believed to be a non-boston scientific lead.We have no information regarding the lead.Our device is l331/972384.Boston scientific technical services (ts) was consulted and stated that since this is a pacemaker dependent patient, they can raise the sensing to 10 to eliminate the issue, they might still see some oversensing.The health care professional (hcp) elected to leave at a setting of 1.5 to eliminate oversensing on the atrial lead, but still wanted to see p-waves.Ts stated this is normal operation for these unipolar leads.Currently both leads remain implanted.The only information we have regarding these leads are the adapters listed.To date, no adverse patient effects have been reported.Additional information received indicates that the ra lead with this adapter exhibited oversensing of myopotential noisy signals that resulted in inappropriate mode switches and pacing inhibition.The health care professional (hcp) reprogrammed one parameter of the device per technical services (ts)'s suggestions.The hcp will discuss further reprogramming with the physician.The adaptor remains in service for approximately 7 years, 8 months.No adverse patient effects were reported.
Additional Manufacturer Narrative
No product was returned to oscor inc.For evaluation, as it remains implanted (approximately 7 years, 8 months); however, a complaint notification was provided.Without the return of the actual device in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections, before shipping to the customer.At this time, it is not possible to assign a definitive root cause for the event as reported, as the adaptor is still in use.The complaint is non-verifiable as the product was not returned for evaluation.No further follow-up is required; the complaint is non-verifiable as the product was not returned for evaluation.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.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: UNIPOLAR LEAD ADAPTOR
• Common Device Name: 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
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 19375275
• Report Number: 1035166-2024-00054
• Device Sequence Number: 15340766
• 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: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

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: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: C/IS-10 SS2
• Device Catalogue Number: C/IS-10 SS2
• Device Lot Number: C1-08766
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown