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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 08/01/2010
Event Type  Injury  
Manufacturer Narrative

Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

It was reported that the pt had surgery to remove the vns device due to infection and cellulitis. Pt went to er on (b)(6)2010 as her caregivers found the generator site had opened up (generator was visible) and was draining. Physician prescribed antibiotics. The device was removed (b)(6)2010 and the infection site was debrided and cleaned. The surgeon thought perhaps the pt's body had rejected the implant which caused the infection. However, per neurologist, the generator became loose and migrated slowly over 5 years to the pt's armpit, and came out. Once it was exposed to air, the infection started. It was also noted that the pt was likely manipulating the device which may have contributed to the events. Pt will be reimplanted in the future in a different location to prevent pt manipulation of the device. Explanted product was returned to the mfr and underwent analysis. Upon analysis, no anomalies were noted. Review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

 
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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 Key1833656
Report Number1644487-2010-02077
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/12/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2005
Device MODEL Number102
Device LOT Number010093
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/19/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/12/2010
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2004
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: 09/10/2010 Patient Sequence Number: 1
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