MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION MOBILE CHARGING SYSTEM; SCS CHARGING SYSTEM

Model Number 3711

Device Problem Temperature Problem (3022)

Patient Problem Discomfort (2330)

Event Date 10/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

Event Description

It was reported the patient (france) experienced redness and discomfort while recharging the ipg.Subsequently, a replacement charger was sent to the patient which resolved the issue.The implant date of the concomitant ipg is unknown at this time.

• Brand Name: MOBILE CHARGING SYSTEM
• Type of Device: SCS CHARGING SYSTEM
• 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
• MDR Report Key: 6264569
• MDR Text Key: 65300395
• Report Number: 1627487-2017-00327
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 3711
• Device Lot Number: 4356772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2013
• 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): Other