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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 105 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 09/24/2014
Event Type  Malfunction  
Event Description

It was reported that the recently implanted vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results revealed high impedance (impedance value = 10,000 ohms). System diagnostic showed lead impedance within normal limits during implant surgery on (b)(6) 2014 (impedance values ¿ 1653 ohms and 1585 ohms). The patient was admitted to the hospital on (b)(6) 2014 and the patient¿s device showed lead impedance within normal limits (impedance values ¿ 4632 ohms, 4306 ohms, and 4197 ohms). On (b)(6) 2014, the patient underwent surgery in which incomplete lead pin insertion was confirmed. After the pin was reinserted, system and generator diagnostic results showed normal device function.

 
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Brand NamePULSE GEN MODEL 105
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 Key4232000
Report Number1644487-2014-02953
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 10/07/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/06/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2016
Device MODEL Number105
Device LOT Number202965
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/13/2014
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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