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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 104 GENERATOR Back to Search Results
Model Number 104
Event Date 03/01/2013
Event Type  Injury  
Event Description

Further follow-up revealed that the physician did not believe that the vns system was related to the infection. Cultures were taken at the hospital; however, the results were not known.

 
Event Description

It was reported that the patient underwent surgery to explant the remaining portion of the lead on (b)(6) 2013.

 
Manufacturer Narrative

Event description, corrected data:the mfr. Report 03 inadvertently reported that the surgery was to replace the remaing portion of the lead.

 
Event Description

Further follow-up revealed that the patient was explanted due to possible infection at the site of incision. Reimplant is planned when the patient has healed. The returned product form indicates the generator and lead were returned; however, the reason was not marked. The op note revealed that the patient has an open wound of the chest and is for repair of chest wound from vagal nerve stimulation hematoma and possible skin flap with removal of vagal nerve stimulation. The generator and lead were received into product analysis on (b)(6) 2013. Analysis of the generator indicated that 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. Analysis of the lead will be reported in mfr report # 1644487-2013-01235.

 
Event Description

It was reported that the patient's generator site was infected and that the patient was referred to surgery. It was reported that the patient was originally scheduled for "closure" surgery; however, the surgeon decided to do a generator replacement to be safe and that it was being considered to place the new generator on the patient's right chest area. It was reported that the surgeon was uncertain if the infection was due to surgery or the presence of the device. There was no trauma or manipulation that occurred; however, it was reported that the patient may have picked at the incision. Clinic notes dated (b)(6) 2013 indicated that the patient had an open wound on the chest and that the patient's father reported that the wound was still draining and that the neurologist recommends that the vns be moved to the right site to allow abscess on the left to heal. Clinic notes dated (b)(6) 2013 indicated that the chest abscess was excised on (b)(6) 2013 and that the patient's mother reported that the wound was draining yellow with some odor. Further follow-up revealed that the patient underwent explant on (b)(6) 2013. It was reported that the plan is to reimplant a vns system in 5-6 months after the wound heals. Both the generator and lead were returned to device manufacturer for analysis on (b)(4) 2013. Product analysis is underway; however, had not yet been completed to date. The patient's father reported on (b)(6) 2013 that he was in the hospital with the patient due to the infection. The father reported that he was under the impression that both generator and lead were explanted; however, the patient underwent a ct scan which showed that a portion of the lead was still implanted. The father reported that the patient's infection has spread to the patient's neck where the lead portion is still implanted. Attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

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

 
Event Description

It was reported that the patient underwent surgery to replace the remaining portion of the lead on (b)(6) 2013.

 
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Brand NamePULSE GEN MODEL 104
Type of DeviceGENERATOR
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 Key3053763
Report Number1644487-2013-00992
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/12/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2014
Device MODEL Number104
Device LOT Number202060
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/08/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received07/12/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/23/2012
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: 04/11/2013 Patient Sequence Number: 1
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