MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-06-17 for EXPLORER FG-6106 DEV 034 manufactured by Card Guard Scientific Survival Ltd..
[1341667]
The patient was enrolled with (b) (4) serial number (b) (4). The original baseline was established on (b) (6) 2007. Transmissions made with the device on (b) (6) 2008, were reported to be of poor quality. After troubleshooting unsuccessfully, the tech placed an order for a replacement device (serial (b) (4)) that arrived on (b) (6) 2008. The replacement device was not activated for baseline service. The pt expired in the evening between (b) (6) 2008 and (b) (6) 2008. At the time of death, it could not be determined if the patient was wearing device serial number (b) (4). Both devices have not been returned for eval. The explorer device is a patient-activated looping cardiac event monitor. Transmissions are sent manually by the patient using a phone. The device is not indicated for use as a real-time ems service.
Patient Sequence No: 1, Text Type: D, B5
[8621144]
The company's initial assessment of this event determined that due to this particular device's capabilities, intended use and the pt required activity to capture an event, it could not reasonably have caused or contributed to this event. After further review, this report is being filed in an abundance of caution to ensure full compliance with 21 cfr part 803. The device was not returned to lifewatch by the patient's family. The device is currently being held by the patient's legal counsel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3027765-2010-00047 |
| MDR Report Key | 1728811 |
| Report Source | 00 |
| Date Received | 2010-06-17 |
| Date of Report | 2008-01-18 |
| Date of Event | 2008-01-03 |
| Date Mfgr Received | 2008-01-18 |
| Device Manufacturer Date | 2006-12-26 |
| Date Added to Maude | 2010-06-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIKAY MENARD |
| Manufacturer Street | O'HARE INTERNATIONAL CENTER II 10255 WEST HIGGINS RD, STE 110 |
| Manufacturer City | ROSEMONT IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8478132977 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPLORER |
| Generic Name | TRANSMITTER&RECEIVERS, ELECTROCARDIOGRAPH |
| Product Code | DXH |
| Date Received | 2010-06-17 |
| Model Number | FG-6106 |
| Catalog Number | DEV 034 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARD GUARD SCIENTIFIC SURVIVAL LTD. |
| Manufacturer Address | 2 PEKERIS ST. P.O. BOX 527 REHOVOT 76100 IS 76100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-06-17 |