MAUDE Adverse Event Report: ALTO DEVELOPMENT CORPORATION A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML); PATIENT CABLE

Model Number	019-540
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: device is an "exempt" device.Complaint was received by distributor (b)(4) via (b)(6) hospital (b)(6).Returned device was received on 7/17/2017.The returned device has been sent out for sterilization as part of the a and e medical decontamination process.Device has not returned in time for initial filing.A follow up report will be conducted.
Event or Problem Description
Phone call was received on 7/12/2017 from distributor of device ((b)(4)) reporting complaint received from director of cardiac surgery at (b)(6) hospital (b)(6) pertaining to a patient cable (disposable myo lead), part number 019-540, lot unknown.The complaint reports the device did not function electronically and would not pace the patient.
Additional Manufacturer Narrative
Note: device is an "exempt" device.Complaint was received by distributor anclote surgical (mr.(b)(6)) via (b)(6) hospital (ms.(b)(6)).Returned device was received on 7/17/17.The returned device has been sent out for sterilization as part of the a&e medical decontamination process.Device has not returned in time for initial filing.A follow up report will be conducted.Returned device has been investigated and is included as part of the follow up report.[(b)(4)].
Event or Problem Description
Phone call was received on 7/12/2017 from distributor of device ((b)(6)) reporting complaint received from director of cardiac surgery at (b)(6) hospital south ((b)(6)) pertaining to a patient cable (disposable myo lead), part number 019-540, lot unknown.The complaint reports the device did not function electronically and would not pace the patient.

• Brand Name: A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML)
• Common Device Name: PATIENT CABLE
• Manufacturer (Section D): ALTO DEVELOPMENT CORPORATION; 5206 asbury road; farmingdale NJ 07727
• MDR Report Key: 6785997
• Report Number: 2242056-2017-00002
• Device Sequence Number: 1490193
• Product Code: IKD
• UDI-Device Identifier: 10841291105282
• UDI-Public: 10841291105282
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2017

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: Physician
• Device Model Number: 019-540
• Device Catalogue Number: 019-540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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