MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

Model Number MODEL 250

Device Problems Premature Discharge of Battery (1057); Failure to Charge (1085)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the battery of a handheld could not keep in charge.If the battery is replaced with a known good working battery, the handheld can be switched on.Review of the manufacturing records indicated that the concerned handheld was reworked during the manufacturing process.A new battery was replaced as this was not keeping charge during the testing.After the battery was replaced, the device passed the final quality inspection tests prior to the distribution.

Event Description

An analysis was completed on the returned handheld.It was verified during the analysis that the main battery was unable to hold a charge and power the handheld.It was also identified that the returned battery was not a dell battery.Once the battery was replaced with a known good battery, the issue solved.An analysis was performed on the returned flashcard and no anomalies were identified during the analysis.

Event Description

An analysis was performed on the returned handheld and the reported allegation was verified.An analysis of the handheld was able to verify that the returned main battery was unable to hold a charge and power the handheld.It was also identified that the returned battery was not an original dell battery, but an alternate battery that is supplied by the manufacturer.Once the battery was replaced with a known good battery, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.It was also reported by the user the battery difference was observed as well when the product pack received the first time.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6089045
• MDR Text Key: 59890175
• Report Number: 1644487-2016-02588
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 250
• Device Lot Number: 1340447
• Other Device ID Number: VERSION 8.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/07/2016; 12/14/2016; 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1