MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-19 for PROGRAMMING SOFTWARE MODEL 250 NA manufactured by Cyberonics - Houston.
[46672345]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[46672346]
A field representative reported that when attempting to interrogate two demo devices an error message was appearing on his tablet programmer. The programming wand battery status was checked and found to be adequate. The user later attempted a different programming wand with the same usb cable and was still unable to interrogate his demo generators. Upon using a replacement usb cable the tablet programming system functioned properly. The suspect usb cables was returned for product analysis. Analysis confirmed a disconnected wire on the usb serial cable printed circuit board (pcb). Once the wire was soldered onto the serial cable pcb no further anomalies were identified and the cable functioned normally.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2016-01069 |
| MDR Report Key | 5667163 |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-05-04 |
| Date Mfgr Received | 2016-05-04 |
| Device Manufacturer Date | 2015-05-14 |
| Date Added to Maude | 2016-05-19 |
| 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 | MRS. NJEMILE CRAWLEY |
| Manufacturer Street | 100 CYBERONICS BLVD SUITE 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal | 77058 |
| Manufacturer Phone | 2812287200 |
| Manufacturer G1 | CYBERONICS - HOUSTON |
| Manufacturer Street | 100 CYBERONICS BLVD SUITE 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77058 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROGRAMMING SOFTWARE |
| Generic Name | PROGRAMMING COMPUTER |
| Product Code | LJY |
| Date Received | 2016-05-19 |
| Returned To Mfg | 2016-05-10 |
| Model Number | MODEL 250 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | VERSION 11.0 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERONICS - HOUSTON |
| Manufacturer Address | 100 CYBERONICS BLVD NA HOUSTON TX 77058 US 77058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-19 |