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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL 102 GENERATOR

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CYBERONICS PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 01/24/2006
Event Type  Malfunction  
Event Description

During programming history review it was discovered that high impedance (dc dc code 5) was obtained approximately two months after the patient underwent generator replacement surgery. Previously it was reported that the high impedance was first obtained on (b)(6) /2006; however, the programming history confirms that the high impedance was first observed on (b)(6) 2006. X-rays reviewed by manufacturer revealed that the lead connector pin was not fully inserted into the generator connector block. The patient underwent revision surgery on (b)(6) 2006. It was noted that the lead was reinserted into the generator header and diagnostic testing was then within normal limits.

 
Manufacturer Narrative

Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3180795
Report Number1644487-2013-01864
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/21/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/20/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2007
Device MODEL Number102
Device LOT Number012830
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/21/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/14/2005
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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