MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM¿ 7 ELITE IPG; SCS IPG

Model Number 3662

Device Problem Device Inoperable (1663)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

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 patient ipg became inoperable during the implant procedure because the ipg was not placed into surgery mode.Troubleshooting was unable to address the issue.As a result, the patient's ipg was explanted and replaced the following day.Surgical intervention addressed the patient's issue.

Event Description

Further review of information gathered clarified/revealed the ipg became inoperable during an unrelated neck procedure following the implant of the initially reported ipg.

• Brand Name: PROCLAIM¿ 7 ELITE IPG
• 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: 7509249
• MDR Text Key: 108079533
• Report Number: 1627487-2018-04775
• Device Sequence Number: 1
• Product Code: LGW
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

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: 02/12/2020
• Device Model Number: 3662
• Device Lot Number: 6307443
• Other Device ID Number: 05415067020222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR