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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 10/01/2014
Event Type  Injury  
Event Description

It was reported that the patient experienced a new type of seizures in the form of clusters. It was also reported that the patient has experienced pain at the generator site. Clinic notes dated (b)(6) 2015 note that the patient's mother reports a significant number of complex absence / confusional episodes one every five days that last two days. The patient's fycompa was increased. It was noted that the patient complained of pain at the generator site when moving both arms. The patient was referred to surgeon for review and or revision of the vns regarding the pain. No additional relevant information has been received to date. No known surgical interventions have been performed to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

This information was inadvertently left off of previous mfr. Report: suspect device udi: (b)(4).

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4632395
Report Number1644487-2015-04231
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2016
Device MODEL Number105
Device LOT Number4033
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/07/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/17/2014
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: 03/25/2015 Patient Sequence Number: 1
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