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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 10/04/2010
Event Type  Injury  
Manufacturer Narrative

 
Event Description

No further information has been attained after good faith attempts have been made.

 
Event Description

It was reported that the patient continues to have left shoulder pain with stimulation. The patient¿s caregiver would like to have the patient¿s lead replaced. She reports that the patient saw the surgeon a year ago about the pain and other events, and the surgeon reported to them that the patient did not need replacement.

 
Manufacturer Narrative

Type of report corrected data; omitted on initial report, 30 day report.

 
Event Description

Additional information was received from a company representative indicating the patient was to undergo surgery as a piece of a foreign object was detected under the patient's shoulder area and believed to be associated with initial vns surgery. Moreover, the patient was reported to have an increase in seizures. Interventions taken were to increase the medication doses. At the moment, attempts to obtain further information regarding the foreign object have been unsuccessful to date.

 
Event Description

It was reported by a patient's mother that the vns patient had recently undergone generator replacement surgery and since then, the patient has experienced an increase in seizures, started having cardiac issues, and constant left shoulder pain. The patient's mother did not know if the reported increase in seizures was above pre-vns baseline, but did mention the patient underwent medication and parameter changes to reduce the seizure frequency. At the moment the relationship of the reported cardiac issue, pain, and increase in seizures to vns therapy is unknown as good faith attempts to obtain further information from the treating epileptologist have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL 104
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 Key2540783
Report Number1644487-2012-01011
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 03/26/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date04/30/2011
Device MODEL Number104
Device LOT Number2412
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Distributor Facility Aware Date08/09/2012
Event Location Other
Date Manufacturer Received02/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2009
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: 04/19/2012 Patient Sequence Number: 1
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