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 05/15/2018

Event Type  Injury  

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 was unable to connect the ipg with external devices following an unrelated surgery.Troubleshooting was tried to no avail.The ipg was deemed inoperable.Surgical intervention may be taken at a later date to address the issue.

Manufacturer Narrative

The patient identifier should have been dc rather than cd.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient underwent surgical intervention wherein the device was explanted and replaced.

• 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
• Manufacturer Contact: taruna sharma ; 6901 preston road; plano, TX 75024 ; 9725269635
• MDR Report Key: 7631194
• MDR Text Key: 112087841
• Report Number: 1627487-2018-05978
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020222
• UDI-Public: 05415067020222
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2018
• Device Model Number: 3662
• Device Lot Number: 5371491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• 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 2331, SCS ADAPTER
• Patient Outcome(s): Other