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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 105 GENERATOR Back to Search Results
Model Number 105
Event Date 08/05/2013
Event Type  Injury  
Event Description

It was reported that the patient has been scheduled for reimplant of a new vns system. The reimplant surgery has not yet occurred.

 
Event Description

The explanted generator and lead were returned to the manufacturer for analysis. The reason for explant was due to infection and no malfunction suspected/identified. Results of diagnostic testing indicated the generator was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Scanning electron microscopy images of the positive coil of the lead show that pitting or electro-etching conditions have occurred on the coil cut end. The most likely cause for the observed pitting condition is that the generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load (cut leads). However, the exact point in time of when this occurred is unknown. Note that since a portion 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. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

 
Event Description

It was reported that the patient had a complete revision surgery on august 5, 2013 and was returning to the operating room on (b)(6) 2013 for another procedure. Operation notes dated (b)(6) 2013 indicate the patient has developed swelling over his pulse generator site over the last 24 hours the patient's mother denies any trauma to the area. The patient¿s axillary incision was opened and yellowish cloudy fluid was observed in the subcutaneous pocket, which was sent for microbiologic analysis. The pulse generator was removed and the pocket was irrigated with large amounts of antibiotic saline. Per the notes, due to the extreme dependency of this patient on his vagal nerve stimulator pulse generator procedure control and his history of refractory epilepsy, it was the surgeon's decision to attempt at first to try to treat the likely infection with a revision of the patient's pulse generator and intraoperative aggressive washout. After soaking the pulse generator in the antibiotic saline tub for a protracted period of time, the device was reconnected to the electrode lead with the torque wrench. It was then re-implanted into the subcutaneous pocket. The device was interrogated and found to be okay. Antibiotic ointment and sterile dressings were placed over the closed skin. The patient left the operating room in stable condition. Operative notes dated (b)(6) 2013 indicate the patient had a postoperative wound infection. Removal of vagal nerve stimulator pulse generator, as well as partial removal of electrode leads and complete drainage postoperative wound was performed. Per the notes, the patient developed a postoperative wound infection which has been shown to be a staph aureus wound infection. Swelling in the patient's chest pocket recurred despite operative washout and neurosurgical intervention was indicated now for removal of the vagal nerve stimulator. The patient was receiving intravenous antibiotics during surgery. During surgery, there was no evidence of obvious purulence in the neck region; however, the physician swabbed the area for intraoperative culture. When entering the subcutaneous pocket, yellowish cloudy fluid was observed. The specimen was sent for microbiologic analysis. The pulse generator and lead were explanted and the pocket was irrigated with large amounts on antibiotic saline. Antibiotic ointment and sterile dressings were placed over the incisions and the patient was taken to recover in the recovery room. No additional information was provided. Review of manufacturing records confirmed there were no unresolved non conformances found and sterility was confirmed with the generator and lead prior to distribution and sterility.

 
Manufacturer Narrative

Suspect medical device explant date, corrected data: the initial report inadvertently reported the incorrect date.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

 
Event Description

It was reported that the patient underwent re-implant surgery. The new lead was placed on the patient's right side.

 
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Brand NamePULSE GEN MODEL 105
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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3316559
Report Number1644487-2013-02561
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 08/06/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2015
Device MODEL Number105
Device LOT Number3620
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/05/2014
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/08/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2013
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: 08/29/2013 Patient Sequence Number: 1
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