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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103 GENERATOR

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CYBERONICS INC PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 12/01/2014
Event Type  Injury  
Event Description

It was reported that the patient was referred for a repositioning surgery due to migration of the generator. The generator had moved to the shoulder and clavicle and was causing pain. Over the past several weeks the patient has complained of left shoulder and clavicle pain. It is almost constant and is particularly brought on by weight lifting and other movements. The patient participates in very strenuous activities and the surgeon believes that these activities caused the generator to break through the encapsulation and migrate upward. System diagnostics were performed which showed the device to be functioning properly, with an impedance value of 2339ohms. The surgeon brought the patient in on (b)(6) 2014 to reposition it lower to help with discomfort.

 
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Brand NamePULSE GEN MODEL 103
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 Key4401903
Report Number1644487-2015-03577
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/16/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2013
Device MODEL Number103
Device LOT Number201739
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/16/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/12/2011
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: 01/09/2015 Patient Sequence Number: 1
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