MAUDE Adverse Event Report: ABBOTT MEDICAL EON MINI IPG, 16-CHANNEL RECHARGEABLE SCS IPG

Model Number 3788

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated. The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

Device 1 of 2; reference mfr. Report#: 1627487-2020-33245. It was reported the patient began to receive ineffective therapy after a car accident occurred. Allegedly, the patient's ipg and lead were found to have been disconnected from each other following the car accident. As a result, the patient decided to have their scs system explanted.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10780959
• MDR Text Key: 214506400
• Report Number: 1627487-2020-33244
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,CONSUM

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/03/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 01/28/2015
• Device MODEL Number: 3788
• Device Catalogue Number: 3788
• Device LOT Number: 3917429
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/18/2013
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data

Patient TREATMENT DATA

Date Received: 11/03/2020 Patient Sequence Number: 1