MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 5 ELITE; SCS IPG

Model Number 3660

Device Problem Device Inoperable (1663)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by (b)(4)on 02 june 2017.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported the ipg was unable to communicate with the external devices.Troubleshooting was unable to resolve the issue.The patient underwent an unrelated surgical procedure on (b)(6) 2018 and the ipg was not placed into surgery mode.Surgical intervention may be pending to address this issue.

Event Description

Follow up information identified there are currently no interventions planned as patient is doing well without stimulation.

Event Description

Follow up information identified the patient is currently receiving anticoagulants thus surgical intervention may be pending to address the issue.

Event Description

Additional information received that patient underwent surgical intervention on (b)(6) 2019 where in the ipg was explanted, replaced and relocated.Therapy restored post-operatively.

• Brand Name: PROCLAIM 5 ELITE
• 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: tanja hoffman ; 6901 preston road; plano, TX 75024 ; 9723098520
• MDR Report Key: 7611631
• MDR Text Key: 111402224
• Report Number: 1627487-2018-05881
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/18/2019

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: 05/23/2018
• Device Model Number: 3660
• Device Lot Number: 5508584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/18/2018
• Supplement Dates Manufacturer Received: 07/09/2018; 08/14/2018; 09/30/2018; 02/25/2019
• Supplement Dates FDA Received: 07/25/2018; 08/24/2018; 10/15/2018; 03/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2016
• 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
• Treatment: MODEL 1192 (2), SCS ANCHOR; MODEL 3186, SCS LEAD; MODEL 3186, SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 91