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

Model Number 019-540

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2017

Event Type  malfunction  

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 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.

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 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)
• Type of Device: PATIENT CABLE
• Manufacturer (Section D): ALTO DEVELOPMENT CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): ALTO DEVELOPMENT CORPORATION; 5206 asbury road; farmindale NJ 07727
• Manufacturer Contact: bill kilby ; 5206 asbury road; farmingdale, NJ 07727 ; 7329282266
• MDR Report Key: 6785997
• MDR Text Key: 82721787
• Report Number: 2242056-2017-00002
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 10841291105282
• UDI-Public: 10841291105282
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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