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

Model Number 3789

Device Problem Delayed Charge Time (2586)

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

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient was experiencing increased recharge burden (ipg would deplete within 3 hours after charging).As a result, the scs ipg was explanted and replaced with a different model.

• Brand Name: PROTEGE IPG, 16-CHANNEL RECHARGEABLE
• 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
• MDR Report Key: 5535260
• MDR Text Key: 41465470
• Report Number: 1627487-2016-01610
• 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: 04/12/2016

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: 05/28/2016
• Device Model Number: 3789
• Device Lot Number: 4606927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR