MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problems High impedance (1291); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

A patient had generator and replacement surgery due to high impedance, as captured in mfr report # 1644487-2016-00649.During surgery, it was identified that the generator header was completely separated from the can.Product analysis of the generator identified that the battery depletion was an expected event as determined by the battery life calculator and battery voltage measurement.Review of the device history record showed no unresolved non-conformances existed prior to device distribution.During the analysis, it was found that there was sufficient adhesive on the header and can indicating that the separation of the header from the can was not due to any sort of manufacturing error.The presence of foreign matter in the feed-thru area and along the header attach area indicates that this condition was present prior to explant however, the exact time at which the separation occurred is unknown.The cause of the detached header could not be ascertained.However, an area of separation between the generator case and header was noted as evident by the foreign matter in the feed-thru area and along the header attach area.

• Brand Name: PULSE GEN MODEL 102R
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5727989
• MDR Text Key: 48349342
• Report Number: 1644487-2016-01345
• 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: Other
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/06/2010
• Device Model Number: 102R
• Device Lot Number: 200859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2008
• 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: 18 YR