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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. GENERATOR MODEL 103

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CYBERONICS, INC. GENERATOR MODEL 103 Back to Search Results
Model Number 103
Event Date 11/30/2011
Event Type  Injury  
Event Description

The explanted generator was returned for analysis. The lead was discarded. Completion of the generator analysis is pending.

 
Event Description

A pediatric epilepsy nurse specialist in the united kingdom reported that they had a vns patient who has had ongoing problems with wound breakdown following vns surgery last (b)(6) (2011). A decision was made to explant the device. The patient has an extensive history of interventions taken to try to prevent the device being explanted and resolve their infection. Date the event 1st observed - was (b)(6) 2011. The patient was admitted to a children's ward with a chest infection. Discharged on (b)(6) 2011 with 1 week oral antibiotics. (b)(6) 2011 - neck wound inflamed (wound swab - scanty growth (b)(6)) treated with 7 days oral flucloxacillin. (b)(6) 2011- wound improving. (b)(6) 2011 - wound improving but not completely healed so continued on oral flucloxacillin. (b)(6) 2012 - wound not completely healed but no sign of infection. (b)(6) 2012 - debridement of neck wound - discharged on oral flucloxacillin. (b)(6) 2012 - neck wound clean; dry. (b)(6) 2012 - admitted to ward with infection in chest and neck wound - 3 weeks if iv antibiotics as an inpatient followed by 3 months oral antibiotics. (b)(6) 2012 - scab remained over neck wound - wire near surface. (b)(6) 2012 - neck wound explored and wire re-positioned. No evidence of infection. (b)(6) 2012 - wounds clean and dry - 3 months of oral antibiotics finished (b)(6) 2012 - area around chest wound appeared swollen but do evidence of infection or wound breakdown. (b)(6) 2012 - chest wound breakdown - no growth on wound swab. (b)(6) 2012 - wounds debrided and re-sutured. (b)(6) growth from tissue sent. Commenced iv antibiotics. (b)(6) 2012 - discharged home on once a day iv antibiotics by community nurses. (b)(6) 2012 - re-admitted with discomfort around chest wound, increased seizures and fluid collection under chest wound. (b)(6) 2012 - device and leads removed. Leads and tissue sent for flu culture - no growth after 48hrs. Continues in iv antibiotics. It was reported that the wound dehiscence and the infection were not related to the vns or the implant procedure although the patient's device was explanted related to the event. Patient manipulation or trauma did not occur that is believed to have caused/contributed to the wound dehiscence or the infection. No causal or contributory medication changes preceded the onset of the dehiscence or the infection. The infection was located at the neck wound. The neck location was re-explored in (b)(6) 2012 as electrodes were near the surface. The lead was re-positioned at this time.

 
Event Description

The patient's explanted generator was returned for analysis. Results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

 
Manufacturer Narrative

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

 
Event Description

Additional information was received. That the patient's increase in seizures were above their pre-vns ratethe patient was given more anticonvulsant medication for the increased seizures. They were possibly due to the ongoing infection.

 
Manufacturer Narrative

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

 
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Brand NameGENERATOR MODEL 103
Type of DeviceGENERATOR MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key2777435
Report Number1644487-2012-02559
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/14/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2013
Device MODEL Number103
Device LOT Number201746
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/15/2012
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date09/14/2012
Event Location Other
Date Manufacturer Received11/20/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/19/2011
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: 10/09/2012 Patient Sequence Number: 1
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