MAUDE Adverse Event Report: CONMED CORPORATION PADPRO MULTIFUNCTION ELECTRODE; DEFIBRILLATOR PADS

Catalog Number	2516M
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device return to conmed is anticipated; however, it has not been received to date.The end-user facility has reported that they will be evaluating the lifepak 20 cardiac monitor.On completion of the quality engineering evaluation a supplemental report will be filed.
Event or Problem Description
As reported, during surgical placement of a biventricular icd (internal cardiac defibrillator), a padpro multifunction electrode was being utilized in conjunction with a lifepak 20 monitor with pacing capability.Signals failed during a period of asystole resulting in the inability to cardiac pace the patient.The surgical team conducted direct left ventricle pacing until the cardiac tracing returned on the lifepak 20.Reportedly the cardiac tracing returned later in the case and then ceased again.There was no injury to the patient and it was reported that the patient was discharged home with no complications experienced after leaving the cardiac lab.
Additional Manufacturer Narrative
The device manufacture date was reported incorrectly on the initial report as 03/20/2015 and the correct date of 09/18/2015 is recorded.Manufacturer narrative: the padpro multifunction electrode was not returned to conmed corporation for evaluation.No visual evidence (photographs) of failure was made available.A failure analysis of the complaint device could not be completed; therefore, any potential anomaly or defect cannot be confirmed and associated failure mode as well as root cause cannot be conclusively determined without examination of the actual device.This lot was manufactured 18-sep-2015.A review of the device history record for this lot found no non-conformances or abnormalities during the manufacturing process that could have caused or contributed to the reported issue.(b)(4).Of (b)(4) similar complaints, all (b)(4) of these evaluations were unable to reproduce the reported events with the returned devices.Therefore, no manufacturing issues were able to be identified with any of the (b)(4) similar complaints.(b)(4).The padpro multifunction electrodes are intended for use during defibrillation, cardioversion, pacing, and ecg monitoring applications.To reduce the risk of patient injury the ifu, instructions for use, provides the following precautions and warnings: no modifications of this device are allowed.Misuse of multifunction electrodes, use of compromised or altered product, and/or failure to follow product instructions may result in patient burns, inadequate delivery of therapy, and/or loss of ecg trace quality.Demand pacing requires separate ecg electrodes and leads for monitoring.Make sure the skin is dry, i.E.Free of water, sweat, alcohol, etc.Do not apply any substance to the skin surface that will leave a residue, i.E.Lotions, oils, etc.Do not re-apply if removed.Avoid storage of electrodes where they may be subject to excessive heat or cold.Electrodes should be stored in unopened pouches at room temperature.Never returned to conmed corporation.

• Brand Name: PADPRO MULTIFUNCTION ELECTRODE
• Common Device Name: DEFIBRILLATOR PADS
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5401241
• Report Number: 1320894-2016-00003
• Device Sequence Number: 505176
• Product Code: MKJ
• UDI-Device Identifier: 10653405042624
• UDI-Public: (01)10653405042624(17)180320(30)1(10)Y03171509
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K020203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Followup
• Report Date (Section B): 01/08/2016

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: 03/20/2018
• Device Catalogue Number: 2516M
• Device Lot Number: Y03171509
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2016
• Supplement Report FDA Received Date: 04/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 86