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

Model Number 104

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 06/15/2015

Event Type  Injury  

Event Description

Additional information obtained from the surgeon indicates that the cause of the generator migration is unknown but may have been related to the substance he observed around the generator, which he believed to be infected tissue, when he opened the pocket.The surgeon stated there was no manipulation or trauma that he was aware of and the patient did not appear to be a twiddler.He stated that non-absorbable sutures were used to secure the generator during its implant.He stated the planned intervention to reposition the device was for patient comfort but the intra-operative removal was deemed appropriate given the finding of what he thought to be signs of an infection.The generator and all but one inch of the electrode portion of the lead were explanted.

Event Description

It was reported that a vns patient would have his device repositioned to address pain caused by generator migration.Clinic notes obtained indicated that the patient¿s treating neurologist noted pain and tenderness at the vns site and stated that the generator had migrated towards the sternum.The patient¿s vns system was tested and showed normal device function.The patient¿s surgeon described that the generator had shifted medially on his chest and overlies the costosternal border, it was uncomfortable with no redness, swelling, inflammation, open wounds, or drainage and that the patient¿s pain was exacerbated by pushing on that area.It was subsequently reported that during the repositioning surgery the surgeon explanted the generator and the lead (electrodes remaining) due to infection.Attempts for additional relevant information have been unsuccessful to date.The reported infection is reported in mfr.Report #: 1644487-2015-05254.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• 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 Key: 4925791
• MDR Text Key: 6077983
• Report Number: 1644487-2015-05251
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2012
• Device Model Number: 104
• Device Lot Number: 2773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/24/2015
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR