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

Model Number 4017

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

Patient Problems Tachycardia (2095); Shock from Patient Lead(s) (3162)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

The lead was in use for treatment.The lead was in service for approximately 20 years, 2 months since it was capped on (b)(6) 2021.The lead was not returned for analysis, therefore, the exact cause of the lead issue cannot be determined and the clinical observation could not be confirmed.However, the following controls are in place to mitigate the reported lead issue.Per qa permanent pacing lead final inspection procedure the lead is checked 100% for electrical function.Final qa inspection of permanent pacing leads includes an insertion/withdrawal force test on is-1 connector on the first and last serial number of the work order and 100% inspection regarding: length measurement of the lead, distal spacing measurement, pull test on the connector, electrical dc resistance is checked ring to ring, pin to tip and pin to ring (on pr leads, helix to connector pin used as contact), "d" dimension on is-1 connector is measured and tubing inspection is done.A general inspection is done of the following: verify proper application of adhesive, check outer hull to inner hull laser weld for proper placement, coil is checked for kinks, the connector sleeve and o-rings are examined for nicks, cuts, excessive flash or excessive adhesive residues on its surface, electrodes are examined for residue and scratches, rotational pin to pin hull laser weld is checked for proper weld, and helix is checked by extension and retraction.Prior to packaging the helix is completely retracted and protector tubing is attached.Although the root cause of this failure could not be determined, potential causes of this failure may be: unsatisfactory electrode position or damaged coating on tip during implant.The potential effects from this type of failure include: less efficient pacing, more frequent battery replacement, intermittent or continuous loss of pacing or sensing, or another procedure may be required for repositioning or removal.The instructions for use (ifu) pr flexion 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.The ifu precautions the user: perform procedure under fluoroscopic guidance.Additionally, the instructions of use of guidant permanent implantable pacing leads (ifu) informs the user of possible complications: with the use of endocardial leads, complications might occur during implantation, explanation, 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.The lead is no longer manufactured.Based on the investigation, a capa is not required as no issues related to design, manufacturing or labeling of the product were revealed.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type.

Event Description

It was reported noise on the right atrial (ra), shock and right ventricular (rv) channels continue.There was oversensing of the noise on the ra channel causing inappropriate atrial tachy response (atr) episodes.The patient was brought in for evaluation where noise on the atrial and shock was able to be reproduced with isometrics.It was noted that in the clinic they did not see oversensing and the stored atr episodes are intermittent with pacing inhibition.The ra lead impedance measurements appear stable.On (b)(6) 2021 this right atrial (ra) lead was capped/abandoned.

• Brand Name: FLEXION 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: 11401646
• MDR Text Key: 234406871
• Report Number: 1035166-2021-00027
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964107
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4017
• Device Catalogue Number: 4017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2021
• 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: 69 YR