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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 09/23/2008
Event Type  Injury  
Event Description

It was reported that a vns patient's device had migrated under her armpit due to unknown reason. No fall or injury preceding migration event was reported. Further information was received from a company representative indicating the patient was recently re-evaluated by her treating physician. Patient was concerned with her device migrating as the patient had been cleaning her fridge vigorously and the suture may have ripped at this point. Patient at this time wants to at least have her generator re-sutured down in the pocket site. However, at the time no additional information has been received indicating a schedule date for the intervention.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1924674
Report Number1644487-2010-02745
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/19/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/07/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/19/2005
Device MODEL Number102
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/19/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2007
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: 12/07/2010 Patient Sequence Number: 1
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