MAUDE Adverse Event Report: OSCOR INC. PY PERMANENT PACING LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number PY 52 PSBV

Device Problems Over-Sensing (1438); Pacing Intermittently (1443); Ambient Noise Problem (2877)

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

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

The lead was used in treatment.The lead was in service for approximately 21 years, 7 months before being abandoned/capped on (b)(6) 2020, therefore the lead was not returned.Based upon the implant date of this lead ((b)(6) 1999), qa is unable to review the device history record for this lead model as it is beyond oscor's record retention period.Inspection procedures require any oscor product to pass all in-process and qa final inspection before shipping to the customer.Per qa procedure permanent pacing lead final inspection, the device is verified 100 percent for electrical and visual function.As stated in the procedure."electrical function: electrical resistance has to be checked with a multimeter.Record ohms readings on work order.Note: on py leads, use helix to connector pin as contact."d" dimensions (is-1 connectors): measure d dimension using optical comparator.Tubing inspection and criteria: all tubing will be inspected according to procedure # (b)(4), "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.(check with z foam dampened with alcohol.)" the py series instructions for use (ifu) informs the user of long term clinical experience for acute and chronic data measurements for sensing threshold and impedance.The instructions for use (ifu) informs the user of these 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 a 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.In addition, the ifu provides the user product awareness: the pacing leads are implanted in the extremely hostile environment of the human body.Because the leads are very small in diameter and must be very flexible, it inevitably reduces their potential performance and longevity.Leads may fail to function for a variety of causes, including medical complications, body rejection phenomenon, fibrotic tissue problem, or a failure of lead by damage, fracture, or by breach of their insulation.Despite of all care in design, component quality, manufacture and testing prior to sale, leads may be damaged by improper handling, use, placement or other intervening facts.The ifu precautions the user: perform procedure under fluoroscopic guidance.This lead is no longer manufactured by oscor.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this device for complaint trends.

Event Description

It was reported this right atrial (ra) lead exhibited noise with oversensing and pacing inhibition.The ra lead was surgically abandoned and a new system was implanted successfully.No additional adverse patient effects were reported.

• Brand Name: PY PERMANENT PACING LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 11368395
• MDR Text Key: 233259533
• Report Number: 1035166-2021-00018
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862330
• 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
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PY 52 PSBV
• Device Catalogue Number: PY 52 PSBV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR