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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 06/20/2014
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

An explanted generator and lead were returned to the manufacturer for analysis in mfr. Report # 1644487-2015-05052. Product analysis was completed for the lead. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. It appears that the incomplete pin insertion condition existed during the time of implant, as no other sets of setscrew marks were observed on the connector pin surface. There was no evidence to suggest an anomaly with the returned portion of the device. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Product analysis was completed for the generator. There were no performance or any other type of adverse conditions found with the pulse generator. It was found that impedance increased from 2268 ohms to 5717 ohms on approximately (b)(6) 2015.

 
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Brand NamePULSE GEN MODEL 105
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key5102882
Report Number1644487-2015-05884
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Report Date 08/28/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/13/2015
Device MODEL Number105
Device LOT Number202801
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/10/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/17/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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