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

Model Number 3662

Device Problem Device Inoperable (1663)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

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.Manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported the patient experienced ineffective stimulation post an unrelated scs system procedure.The patient failed to set the ipg in surgery mode.In turn, the rep was unsuccessful reprogramming the ipg.System diagnostics revealed the ipg deemed inoperable.Surgical intervention may take place at a later date to address the issue.

Event Description

Additional information received identified the patient underwent surgical intervention wherein the ipg was explanted and replaced.Effective therapy was achieved post operatively.

• Brand Name: PROCLAIM 7 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
• MDR Report Key: 7550474
• MDR Text Key: 109493967
• Report Number: 1627487-2018-05246
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 3662
• Device Lot Number: 5432858
• Other Device ID Number: 05415067020222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 78 YR
• Patient Weight: 91