MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-16 for PROGRAMMING SOFTWARE MODEL 250 NA manufactured by Cyberonics - Houston.
[46511596]
Patient Sequence No: 1, Text Type: N, H10
[46511597]
A handheld device (hhd) was received with an ac adapter, serial cable, flashcard software, and programming wand. Upon receipt, the main battery was depleted. The handheld device was powered using the returned ac power supply with no anomalies. During startup, the charge light on the power button was flashing green and amber indicating that the main battery was not being charged reliably by the handheld. The hhd was opened and a visual inspection identified that the solder connections between the main battery terminal and main board were broken. Once the connections were re-soldered, battery charging returned to normal and the handheld device functioned normally. The handheld was powered-on continuously using only the main battery for more than an hour. At the conclusion of testing, the main battery had a remaining charge of 42%. No other anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. No anomalies were found with the returned programming wand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2016-01024 |
| MDR Report Key | 5656619 |
| Date Received | 2016-05-16 |
| Date of Report | 2016-05-09 |
| Date of Event | 2016-05-09 |
| Date Mfgr Received | 2016-05-09 |
| Device Manufacturer Date | 2008-01-31 |
| Date Added to Maude | 2016-05-16 |
| 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 | 2016-05-16 |
| Returned To Mfg | 2016-04-18 |
| Model Number | MODEL 250 |
| Catalog Number | NA |
| Lot Number | 841226 |
| ID Number | VERSION 8.0 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-05-16 |