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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/24/2014
Event Type  Injury  
Event Description

It was reported that the patient was scheduled for exploratory surgery and possible generator replacement. It was reported that the patient experienced pain (9/10) at the generator site which the patient was seen at the emergency room for. The physician reported that the pain has been occurring for approximately three months and the pain goes from the generator to the patient's shoulder down into the patient's arm which the physician reported is not a normal radicular pattern. It was reported that cardiac issues and pulmonary embolism were ruled out. A ct scan of the chest did not identify any abnormal fluid collections around the generator. It was reported that the patient underwent exploratory surgery with generator replacement due to ifi - yes on (b)(6) 2014. Attempts to obtain additional information have been unsuccessful to date.

 
Event Description

The vns physician reported that the patient had not been seen for about three years. The physician's office has not received any further reports of pain from the patient, and to their knowledge, the implanted vns system was working properly at the time of the reports of pain. Information obtained indicates that the explanted devices were sent to the hospital's pathology department after surgery and subsequently discarded.

 
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Brand NamePULSE GEN MODEL 103
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 Key3718781
Report Number1644487-2014-00853
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/04/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2010
Device MODEL Number103
Device LOT Number200759
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/13/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/24/2008
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: 04/01/2014 Patient Sequence Number: 1
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