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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 01/01/2011
Event Type  Injury  
Event Description

An implant card was received indicating that the patient underwent generator replacement due to pain in chest. The lead impedance was marked as ok. Attempt to obtain additional information have been unsuccessful to date. It is unknown if the generator will be returned for analysis as the generator has not been received to date.

 
Event Description

On (b)(4) 2013, it was reported that if the generator had not been returned, it was likely discarded. Attempts for additional information have been unsuccessful as the physician reported the information was confidential.

 
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3317147
Report Number1644487-2013-02564
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2008
Device MODEL Number102
Device LOT Number016522
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/20/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/16/2007
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: 08/29/2013 Patient Sequence Number: 1
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