MAUDE Adverse Event Report: CYBERONICS, INC. PROGRAMMING WAND

Model Number 201

Device Problems Image Display Error/Artifact (1304); Difficult to Interrogate (1331)

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

Event Date 09/12/2016

Event Type  malfunction  

Event Description

It was reported by a physician that a handheld programmer was giving him trouble upon interrogation.He stated that the screen would freeze on the device.Additional relevant information has not been received to-date.

Event Description

Follow-up from the physician provided that the screen freezes and that communication does not happen until the cable is moved around.

Manufacturer Narrative

Event description, corrected data: part of the event description information was inadvertently not provided in the initial report.Brand name, corrected data: the brand name of the suspect device was inadvertently provided incorrectly in the initial report.Type of device, corrected data: the type of device of the suspect device was inadvertently provided incorrectly in the initial report.Model #, corrected data: the model number of the suspect device was inadvertently provided incorrectly in the initial report.

Event Description

The physician reported that the screen would freeze and he often would need to move the wand cable for it to transmit, indicating the programming wand as the suspect device.

Event Description

Follow-up from the physician provided that communication errors occurred intermittently, but could be resolved with difficulty by manipulating the wand cable.However, sometimes during the communication the screens would freeze during the attempts to interrogate.

Manufacturer Narrative

Event description, corrected data: it was inadvertently not provided on follow-up report #4 that the programming wand had been received, and that analysis had been completed device available for evaluation, corrected data: the date the device was received was inadvertently not provided on follow-up report #4.Follow-up type, corrected data: the ¿device evaluation¿ field was inadvertently not marked on follow-up report #4.Device evaluated by mfr, corrected data: the ¿yes¿ field was inadvertently not marked on follow-up report #4.Evaluation codes, corrected data: the evaluation codes were inadvertently not provided on follow-up report #4.

Event Description

The programming wand was received and analysis was performed.The reported mechanical problem and serial adapter cord failure was not confirmed.No visual or mechanical anomaly was identified.Continuity testing of the serial data cable and the battery cable passed.The device performed according to functional specifications.

Event Description

Analysis was completed on the returned handheld programmer and no anomalies were noted during testing.The handheld performed according to functional specifications.Analysis was performed on the returned flashcard.No anomalies associated with flashcard software or databases were identified and they performed according to functional specifications.

• Brand Name: PROGRAMMING WAND
• Type of Device: PROGRAMMING WAND
• 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: 6012920
• MDR Text Key: 57101394
• Report Number: 1644487-2016-02292
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/07/2017

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: 201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 11/03/2017; 12/07/2017
• Supplement Dates FDA Received: 12/13/2016; 01/19/2017; 02/28/2017; 11/28/2017; 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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