MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102R; GENERATOR

Model Number 102R

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2018

Event Type  malfunction  

Event Description

It was reported that the patient¿s m102r device could not be interrogated and he is going to have the device replaced.After the replacement it was noted that the explanted generator was not attached to the header.There was no evidence of lead fracture and normal impedance was recorded with the new implanted generator.The or specialist reported that the detachment was noticed when the surgeon opened the pocket.She was unable to interrogate the device pre-op due to battery depletion.The explanted generator has been disposed of and is not available for return.No additional or relevant information has been received to date.

Event Description

Additional information was received from the surgeon that the believed cause of the detachment of the header was battery replacement.

• Brand Name: PULSE GEN MODEL 102R
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, 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: 7542255
• MDR Text Key: 109234900
• Report Number: 1644487-2018-00866
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2009
• Device Model Number: 102R
• Device Lot Number: 016999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2007
• 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: 30 YR