MAUDE Adverse Event Report: PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Convulsion, Clonic (2222); Post Operative Wound Infection (2446)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? code 81.Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

It was reported by the surgeon that the patient generator became infected and was explanted.Additional information was received from the patient noting that they were fine post-implant and were doing well during titration.Seizures were improving overall.They then observed that the surgical site seemed swollen and one end of the incision was not healing properly.She informed the pa during a virtual visit however pa did not agree and felt it was healing well.The patient then had 2 huge seizures at the end of the week, started shivering uncontrollably and had a fever.The patient went to the hospital and was given antibiotics, then sent home.Before the end of the day, the patient was in sepsis and had to return to the hospital which lead to an emergency surgery to have vns removed.The patient had a staph infection and had to stay in the icu for a week.A week after she was released, the patient had to return to have emergency surgery as the infection returned and there was an abscess where the stitch was left in.After another week, the patient reported having another abscess which was aspirated instead of surgery.The patient recently just has a fever and pain.The device history records of the generator and lead were reviewed.The generator and lead passed final quality and functional specifications prior to release.The products were confirmed to have been sterilized prior to being released for distribution.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.

Event Description

Information was received that the patient phad a full revision due to infection.An implant card was received noting they have been reimplanted.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• MDR Report Key: 12075401
• MDR Text Key: 258643129
• Report Number: 1644487-2021-00876
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2022
• Device Model Number: 1000
• Device Lot Number: 205329
• Event Location: Other
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2020
• 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: 38 YR