MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON RECHARGEABLE IPG, 16-CHANNEL; SCS IPG

Model Number 3716

Device Problem Temperature Problem (3022)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy dates: model: 3701, scs charging system, therapy date: not applicable.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.

Event Description

Device 1 of 2: reference mfr.Report#: 1627487-2019-01124.It was reported the patient had been experiencing uncomfortable heating at their pocket site while recharging their ipg.The patient was able to address the issue with a replacement/different model charging system.

Event Description

Device 1 of 2; reference mfr.Report#: 1627487-2019-01124.Follow-up revealed the patient's ipg was explanted and replaced due to the pocket heating issue that was initially reported, along with the ipg allegedly reaching end-of-life.Surgical intervention addressed the patient's issue.

• Brand Name: EON RECHARGEABLE IPG, 16-CHANNEL
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8272012
• MDR Text Key: 133901819
• Report Number: 1627487-2019-01123
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2008
• Device Model Number: 3716
• Device Catalogue Number: 3716
• Device Lot Number: 50958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68