MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNK; GENERATOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Seizures (2063); Tingling (2171); Numbness (2415)

Event Date 08/01/2016

Event Type  Injury  

Event Description

It was reported on 08/17/2016 from the patient's mother that she was concerned that her daughter's generator battery may be depleted due to recent reports that she has had more seizure events.It was reported that this has only been occurring this month.The patient has been having a feeling of "pins and needles all over her head, arms, and legs" which also leads her mother to fear that her seizures may be returning.No additional information has been received to date.

Event Description

On (b)(6) 2016 it was reported that the patient had not been seen since (b)(6) 2014.No additional relevant information has been received to date.

Event Description

The patient underwent battery replacement on (b)(6) 2016 for battery depletion.The product was discarded after surgery is not available for return.

Manufacturer Narrative

Supplemental mdr #2 inadvertently omitted information that changed the file from a malfunction to serious injury.Information was known prior to submission that intervention was taken for the adverse event.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• 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: 5935884
• MDR Text Key: 54673061
• Report Number: 1644487-2016-02020
• Device Sequence Number: 1
• Product Code: LYJ
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/18/2016; 12/06/2016; 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR