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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK GENERATOR Back to Search Results
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.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
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 Key5935884
Report Number1644487-2016-02020
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Followup,Followup,Followup
Report Date 08/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/08/2016
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
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/16/2016
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 TREATMENT DATA
Date Received: 09/08/2016 Patient Sequence Number: 1
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