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

Model Number 3788

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Type  malfunction  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event, patient and device information.Event date is unknown.

Event Description

It was reported that the patient was experiencing heating at the ipg site.This may be related to recharging.

Manufacturer Narrative

The reported event for the generator and charger become hot during charging was confirmed in the investigation for capa 118058.The corrective action for this issue is for the patient to swap out the high energy (he) charger (3721) for a low energy (le) charger (3722).Actions have been taken to prevent reoccurrence.The patient did not participate in the charger swap.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12104461
• MDR Text Key: 259595244
• Report Number: 1627487-2021-15329
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402651
• UDI-Public: 05414734402651
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 3374028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/07/26/2012/001-C
• Patient Sequence Number: 1
• Treatment: CHARGING SYSTEM.