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Model Number 104
Event Date 12/13/2011
Event Type  Malfunction  
Event Description

Reporter indicated a patient presented on (b)(6) 2011, with swelling around the vns generator site, increased seizures, and high lead impedance with vns diagnostics testing. The patient recently had vns generator replacement surgery performed on (b)(6) 2011, and all vns diagnostics were normal at the surgery. The patient had vns lead pin reinsertion surgery performed on (b)(6) 2011, which resolved the high lead impedance. It was noted during the surgery that one of the lead pins had "popped out" of the generator header. The lead pins were then secured appropriately into the generator header. Vns diagnostics following the lead pin reinsertion were within normal limits. Attempts for further information are in progress.

Event Description

Reporter indicated the increased seizures the patient experienced were due to the high lead impedance. The seizures were not above pre-vns baseline level and the seizure type was not known.

Event Description

Reporter indicated the patient's vns generator site incision had opened up (wound dehiscence), and the vns lead was visible within the wound. There was not an infection present, and it is unknown why the wound opened up. There was no trauma, and it is not felt the patient manipulated the vns, though she is developmentally delayed. There does not appear to be any hygiene issues, as it was felt the patient was very well cared for at home by her mother. The patient had exploratory surgery performed on (b)(6) 2012. The patient is on antibiotics because she had an open wound. At the (b)(6) 2012, surgery, the wound was washed out and debrided and closed, but no devices were explanted. The patient was seen on (b)(6) 2012 and is doing well.

Event Description

Per the patient's caregiver, on (b)(6) 2012, the patient's incision sites appeared purple and the patient had debridement and irrigation of the vns generator area, and the generator was moved to a new pocket. The patient then had vns prophylactic generator and lead replacement surgery performed on (b)(6) 2012, due to desiring a newer vns model. The vns may have been placed in the right chest due to the patient's continued wound healing problems and possible infection. An implant card was received indicating the vns generator and lead had been replaced due to "malfunction". The explanted vns generator and lead remnant were received for analysis on (b)(6) 2012 and are pending analysis. The vns generator was interrogated successfully in the product analysis lab and did not display any abnormalities upon interrogation. Attempts for further information regarding the wound healing and possible infection are in progress.

Event Description

Reporter indicated the new vns generator was implanted in the right chest due to the previous poor healing issues in the left chest incision area. The new lead was tunneled diagonally across the chest. It was unknown what to attribute the poor wound healing to, as the patient had no trauma and it was not felt there had been any device manipulation by the patient. The patient was last seen on (b)(6) 2012, and has been released back to the care of her neurologist, with instructions to call the surgeon's office if issues arise. There have been no calls about the patient since she was seen on (b)(6) 2012. There was no infection present in the wound, but the lead was extruding through the skin prior to the (b)(6) 2012 surgery. The cause of the poor wound healing is unknown, and there was no known trauma or device manipulation by the patient. Additional manufacturer follow up with the treating neurologist's office revealed, the patient is doing well since the surgery, and there have been no issues with the wound healing. Product analysis of the explanted lead and generator was completed. Note that since the majority of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the pin surface. However, the generator and lead were received connected together, and the generator was programmed on; the generator was outputting to an open load. Other than the above mentioned observations and the typical wear and explant related observations, no product related anomalies were identified in the returned lead portion. Results of generator diagnostic testing and monitoring indicated the device was operating properly and that the battery was at an "ifi = yes" condition. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative

Describe event or problem, corrected data: information regarding the increased seizures was inadvertently omitted from follow-up mdr #1.

Manufacturer Narrative

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

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Type of DevicePULSE GEN MODEL 104
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2408227
Report Number1644487-2012-00075
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 12/14/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device EXPIRATION Date08/31/2011
Device MODEL Number104
Device LOT Number2528
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/29/2012
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/10/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/06/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 01/10/2012 Patient Sequence Number: 1