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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 04/28/2008
Event Type  Injury  
Event Description

Additional information was received on (b)(6) 2012 when the neurologist's office reported that they have not seen the patient since 2008 so they would not be able to comment on the events reported by the patient. It is unknown who the patient will see at this time.

 
Event Description

It was reported on (b)(6) 2012, that a patient has felt a ringing in his left ear since surgery and indicated it interferes with his hearing. He has a scar at the generator site which is sensitive and painful. The scar at the generator is large and there is no scarring at the neck site. The patient is experiencing an irregular heartbeat with stimulation. He stated his heart has been observed as "skipping a beat" and states the device affects his memory in that he is unable to remember some things. He can also feel stimulation in his leg at times. Good faith attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

 
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Brand NamePULSE GEN MODEL 102
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2581381
Report Number1644487-2012-01265
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 04/25/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2009
Device MODEL Number102
Device LOT Number1970
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received05/22/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/26/2007
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: 05/21/2012 Patient Sequence Number: 1
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