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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 10/09/2012
Event Type  Injury  
Event Description

It was reported by a vns implanting surgeon that his patient was in hospital with an infection at the generator site. The patient recently had a battery replacement for end of battery life on (b)(6) 2012. On (b)(6) 2012 - the mother reported that her child was fine and no sign of any problems. Somewhere in between tuesday and friday, he began to lose appetite, get sick, developed a low-grade fever, then had redness and swelling at incision site. No report of any draining or bleeding. He was taken to the emergency room and given iv antibiotics and then po clindamycin. The patient was then told to return to ent surgeon first thing (b)(6). On (b)(6), it was reported that the patient was doing better now, has increased appetite and the fever is down. The incision is healed and intact, however, there is still redness and swelling - a fluid-like feeling around the incision. The surgeon reported that he recalls a hard calcification during surgery that had formed around first generator and he removed it during the replacement procedure. He feels some fluid may have accumulated and gotten infected. They did take blood cultures. He planed to admit the patient into the hospital for a couple of days and administer iv antibiotics. (b)(6) the surgeon reported patient is overall a 'lot' better, fever is gone, skin has cleared except for a slight pinkish color localized to generator. Fluid collection is down and he can feel the generator. The surgeon was keeping the patient in hospital on iv antibiotics until 18th, then releasing on antibiotics po. The surgeon planned to aspirate fluid collection around the generator in a week, unless the patient worsened. If patient's infection worsened, he would explant their generator and attempt to salvage the lead. The surgeon is attributing the event to surgery - in particular, the result of the removal of hard calcification that had formed around the generator. He feels that may have left the tissue raw, and caused fluid to collect. He didn't feel it was due to any interaction from the patient. The patient's generator extruded and it was explanted on (b)(6) 2012. Good faith attempts are underway to obtain culture results.

 
Event Description

Additional information was received from the patient's surgeons office in regards to culture results in the patient's vns generator pocket. Rare white blood cells, no bacteria seen.

 
Event Description

Clinic notes dated (b)(6) 2012 were received which summarize the reported infection event. On the patient's last visit to vns battery was dead. Patient had been vns generator battery replaced on (b)(6) 2012, that got infected seen and er at enterprise treated with clindamycin developed cellulitis and subsequently had incision break down and had the procedure done for removal of the vns generator. The notes state that the patient came in on this day for a follow up after having the vns stimulator removed. Two weeks after the patient had a battery implant, he had developed a severe infection for which he was placed on vancomycin iv from (b)(6) 2013 to (b)(6) 2013. This infection progressed to the degree that he could not lift his arm. This continued to progress to the point that the suture line ruptured and the entire stimulator pushed out of his skin. He ended up having it removed on (b)(6) 2013 and stayed in the hospital until (b)(6). He has completed a course of two weeks of clindamycin after being hospitalized and he is no longer on abx. Since the surgery, he initially had an increase in seizure activity but that has decreased to his baseline levels. He continues to have one to two of his more severe seizures per week with other petit seizures interspersed. His lead remain in place at this time.

 
Event Description

The lead was explanted and replaced on (b)(6) 2013.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization prior to shipment of their generator.

 
Manufacturer Narrative

This information was inadvertently left off of mfr. Report #3.

 
Event Description

It was reported that prior to lead replacement and generator implant surgery the patient's wbc count was "a little elevated". The patient had a temperature of 100. 4 degrees following the surgery at 10pm and then by 3am the temperature was 104. 2 degrees. It was reported that the fever broke between 3 am and 6 am that morning.

 
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Brand NamePULSE GEN MODEL 102R
Type of DevicePULSE GEN MODEL 102R
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2822202
Report Number1644487-2012-02912
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/07/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number102R
Device LOT Number202130
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/16/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/10/2012
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: 11/07/2012 Patient Sequence Number: 1
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