MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-04-20 for PATIENT KIT ESSENTIALS 220-3 OR 4 * manufactured by Cyberonics, Inc..
[725693]
Reporter indicated that the magnet had cracked and was no longer working. The pt was not available to perform troubleshooting to determine if the cracked magnet was initiating a magnet mode stimulation. The cause of the cracked magnet is unknown.
Patient Sequence No: 1, Text Type: D, B5
[7865026]
Device failure suspected, but did not cause or contribute to death or serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644487-2007-00311 |
| MDR Report Key | 917493 |
| Report Source | 00 |
| Date Received | 2007-04-20 |
| Date of Report | 2007-03-21 |
| Date of Event | 2007-03-21 |
| Date Mfgr Received | 2007-03-21 |
| Date Added to Maude | 2007-09-24 |
| 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 | 0 |
| Manufacturer Contact | DONNIE WELTY, RN, BSN |
| Manufacturer Street | 100 CYBERONICS BLVD. STE 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal | 77058 |
| Manufacturer Phone | 2812287200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT KIT ESSENTIALS |
| Generic Name | IYJ |
| Product Code | IYJ |
| Date Received | 2007-04-20 |
| Model Number | 220-3 OR 4 |
| Catalog Number | * |
| Lot Number | 388209 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 890222 |
| Manufacturer | CYBERONICS, INC. |
| Manufacturer Address | * HOUSTON TX * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-20 |