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 Date 06/07/2013

Event Type  Injury  

Manufacturer Narrative

¿date of event¿ is estimated.During processing of this complaint, patient weight and complete event information were not requested due to patient not consenting to further contact.The investigation for capa (b)(4) associated with heating while charging (pocket heating) concluded that the charger was capable of transferring energy to the ipg at a rate that would cause heating of the ipg and/or charging wand of sufficient elevated temperature to cause pain and burns.The heating while charging was determined to be exacerbated by off-axis charging of shallow implanted ipgs and that all chargers were capable of elevated heating.The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-32202.It was reported that patient experienced ipg pocket heating while charging ipg.As a result, surgery occurred during which the ipg was explanted.The date of explant is unknown.

Manufacturer Narrative

It was reported to abbott that the patient experienced extreme heating while charging system.The patient reported in (b)(6) 2013 that he experienced extreme heating while charging so patient has stopped using the device and wanted to be explanted.Both leads and ipg were explanted without replacement in (b)(6) 2012 due to pocket heating.The results of the investigation are inconclusive, and the root cause of the reported incident is unknown as the device was not returned for analysis.

• 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: 10668163
• MDR Text Key: 211096379
• Report Number: 1627487-2020-32201
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Model Number: 3788
• Device Catalogue Number: 3788
• Device Lot Number: 3511180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2020
• 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; CHARGING SYSTEM
• Patient Outcome(s): Other