MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

It was reported that during a near end-of-service battery replacement surgery, a calcified tissue was identified on the upper right portion of the generator can, below the header.The surgeon suspected that the area with calcification was a result of corrosion.The calcified tissue was chipped away from the generator.Systems diagnostics at pre-surgery and during surgery were reported to be within normal limits.There was no tissue located at the header or the welded seam of the generator can.No infection was noted in the area.The product has been received for analysis, which has not been completed to-date.

Event Description

Analysis was completed on the returned generator.Other than typical explant procedure related observations, no surface abnormalities, such as sharp edges, header delamination, open pockets, decomposition, corrosion, or voids were noted on this device.There were white deposits on the can.A scanning electron microscopy analysis of the foreign matter indicated that it was calcium and phosphorus.There was no evidence of dried body fluid or corrosion in the connector block.There was no indication from the device that an end of service condition existed.A battery life calculation resulted in 0.50 years remaining before the elective replacement indicator flag would be set.Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• 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: 5159392
• MDR Text Key: 28958106
• Report Number: 1644487-2015-06163
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2008
• Device Model Number: 102
• Device Lot Number: 015424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2006
• 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 Age: 13 YR