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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 04/14/2011
Event Type  Injury  
Event Description

It was reported on (b)(6) 2012, by a caregiver to the manufacturer that the vns patient had surgery on (b)(6) 2011, due to generator migration, infection and wound dehiscence at the generator site. The patient recovered per the caregiver until (b)(6) 2012, when it was noted there was swelling and redness along the vns lead wire in the neck area. On (b)(6) 2012, the patient had surgery to debride the neck area, and the patient was given antibiotics. The wound was also packed daily with gauze. 8 weeks after the surgery the wound opened up and the patient was again put on antibiotics. It was previously reported by the treating surgeon that no infection was present at the generator site at the time of surgery on (b)(6) 2011, but wound dehiscence and migration at the generator site had occurred. Clinic notes were also received from the treating surgeon documenting the neck abscess/dehiscence reported by the caregiver, and that cultures of the neck wound site noted rare (b)(6) bacteria. The patient had developed a neck abscess that had healed, but subsequently opened up recently and was very superficial. The area was cauterized with silver nitrate. The patient was also on oral antibiotics. The patient also has a chest seroma in the area of the vns generator that may be due to trauma, and is being watched for now. Additional manufacturer follow-up with the treating surgeon revealed the neck abscess/dehiscence was felt to be due to trauma and patient manipulation. No medication changes contributed to the events, and no additional interventions have been performed for the neck abscess/dehiscence or chest seroma. The patient is recovering per the surgeon.

 
Event Description

Reporter indicated the patient would have vns lead and generator explant surgery due to infection at the left chest generator site. Prior to the surgery, it was noted on (b)(6) 2012 that the chest wound was opened. The patient had developed seromas of the neck and chest over the last year, which were opened up and packed. The seromas had abscesses. The neck wound had recently healed. The chest wound was packed with nu gauze, and the patient was to continue daily wound packing. The patient later had generator and lead explant surgery performed on (b)(6) 2012. No new devices were implanted. The generator only was returned and is pending analysis. Attempts for further information are in progress.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

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

 
Event Description

Reporter indicated that a patient presented on (b)(6) 2011 with vns generator migration to the axilla along with generator extrusion through the skin. No infection was present. It was unknown what caused the migration or generator extrusion to occur, or if anything precipitated the events. It is not known if the patient had any trauma or if device manipulation occurred. The patient is developmentally delayed. The generator was surgically repositioned on (b)(6) 2011 in a new pocket under the pectoralis muscle and was secured to the fascia with a silk suture. No devices were explanted. The patient was also given antibiotics and is healing well.

 
Event Description

Reporter indicated the patient developed seromas in the chest and neck that later developed into abscesses, which is why the patient's vns was explanted. The events are felt to be related to trauma to the arms and neck by the patient's attendants while repeatedly moving the patient. The patient is recovering satisfactorily from the explant surgery. Analysis of the explanted vns generator was completed. Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator shows no evidence of bodily fluid remnants in the case/header areas. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

 
Event Description

Reporter indicated the patient may be reimplanted with the vns in the future, but no surgery has been scheduled to date. The vns has been helpful for the patient's seizures in the past per the reporter.

 
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Brand NamePULSE 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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2098698
Report Number1644487-2011-01111
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/19/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/14/2010
Device MODEL Number102R
Device LOT Number2187
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/02/2012
Is The Reporter A Health Professional? No
Date Manufacturer Received03/01/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/01/2008
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: 05/18/2011 Patient Sequence Number: 1
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