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

Model Number 3662

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/03/2016

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

The patient received two ipgs (model 3662).It was reported during postoperative recovery (reference mfr report#1627487-2015-20630) one of the two new implanted ipgs would not communicate with the ipad and ipod and subsequently displayed an error message.Troubleshotting with alternative external devices produced identical results.Follow-up identified the ipg for the occiptial system was explanted and replaced with a new model.The issue is resolved.It's unknown which lead model (3066, 3086) is associated with this system.

Manufacturer Narrative

The capa was initiated on (b)(6) 2016 to address the issue in which the ipg experienced loss of power, causing the patient to loose pain relief requiring replacement of the device.Investigation is currently in progress.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.

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.

• 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: 5462979
• MDR Text Key: 39109900
• Report Number: 1627487-2016-00877
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2017
• Device Model Number: 3662
• Device Lot Number: 5307644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-060217-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR