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

Model Number 3662

Device Problems Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inaccurate elective replacement indicator advisory notice issued by abbott on 12 september 2017.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that diagnostics indicated the patient's ipg went into service app mode following an unrelated surgery in which surgery mode was not activated.Surgical intervention may take place to explant and replace the ipg.

Manufacturer Narrative

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.Further patient information was requested but not received.

Event Description

It was reported during follow up that the patient underwent surgical intervention during which the patient's ipg was explanted and replaced.Surgery addressed the issue.

• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8902569
• MDR Text Key: 154589161
• Report Number: 1627487-2019-08737
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2017
• Device Model Number: 3662
• Device Lot Number: 5327601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75