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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
Device Problems Migration or Expulsion of Device ; Unexpected Therapeutic Results
Event Date 01/01/2015
Event Type  Injury  
Event Description

Analysis of the generator was completed on 04/15/2015. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specification. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 04/14/2015. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

 
Event Description

It was reported that the patient was not tolerating the system and would undergo explant. The patient reported that the device was programmed off in 2008 due to lack of efficacy. The patient reported that the generator site is currently tender, sore and itches and she can see the shape of the device under her skin. The patient also indicated that she can feel the lead electrode pushing up against the skin like "it wants to poke out". The patient reported that the seizures are pre-vns baseline frequency. The patient indicated that she wants the device explanted. The patient underwent generator and lead explanted due to pain and hoarseness. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

 
Manufacturer Narrative

Corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key4674518
Report Number1644487-2015-04431
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2007
Device MODEL Number102
Device LOT Number012704
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/27/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/11/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2005
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: 04/09/2015 Patient Sequence Number: 1
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