MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROTEGE; SCS IPG

Model Number 3789

Device Problems Low impedance (2285); Delayed Charge Time (2586); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2014

Event Type  Injury  

Manufacturer Narrative

Results: the complaint was not confirmed.Visual inspection of the returned ipg did not reveal any anomalies that would contribute to the complaint.The ipg was functionally tested and passed all testing.The battery capacity exceeded the expected calculated stimulation time.The ipg charged normally with lab equipment.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's ipg is discharging daily after fully recharging.The patient has been experiencing increase recharge burden since implant.The ipg is able to communicate with the external devices.A replacement charging system was sent to the patient and did not resolve the issue.Surgical intervention is planned to investigate the issue due to the borderline low impedances.Follow up information identified the patient underwent surgical intervention to remove and replace the ipg.

Manufacturer Narrative

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.

• Brand Name: PROTEGE
• 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 DIVISION; 6901 preston road; plano TX 75024
• MDR Report Key: 4358227
• MDR Text Key: 15438815
• Report Number: 1627487-2014-22042
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 3789
• Device Lot Number: 4483196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2014
• 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
• Treatment: MODEL 3214, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 53 YR