MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2017-08-10 for A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML) 019-540 manufactured by Alto Development Corporation.
[82721787]
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.
Patient Sequence No: 1, Text Type: N, H10
[82721788]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242056-2017-00002 |
| MDR Report Key | 6785997 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2017-08-10 |
| Date of Report | 2017-08-10 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-12 |
| Date Added to Maude | 2017-08-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BILL KILBY |
| Manufacturer Street | 5206 ASBURY ROAD |
| Manufacturer City | FARMINGDALE NJ 07727 |
| Manufacturer Country | US |
| Manufacturer Postal | 07727 |
| Manufacturer Phone | 7329282266 |
| Manufacturer G1 | ALTO DEVELOPMENT CORPORATION |
| Manufacturer Street | 5206 ASBURY ROAD |
| Manufacturer City | FARMINDALE NJ 07727 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07727 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML) |
| Generic Name | PATIENT CABLE |
| Product Code | IKD |
| Date Received | 2017-08-10 |
| Returned To Mfg | 2017-07-17 |
| Model Number | 019-540 |
| Catalog Number | 019-540 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTO DEVELOPMENT CORPORATION |
| Manufacturer Address | 5206 ASBURY ROAD FARMINGDALE NJ 07727 US 07727 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-10 |