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

Model Number 3660

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/01/2019

Event Type  Injury  

Event Description

It was reported the patient's scs system patient controller (pc) was displaying ¿connection problem with the generator.¿ reportedly, this issue began for the patient after undergoing a surgical procedure and it was unknown if the device was set to surgery mode.A company representative met with the patient and attempted to resolve the issue with troubleshooting, but the issue persisted.Surgical intervention may be necessary to replace the patient's scs ipg.

Event Description

Follow up information received identified the patient's device was working.However, a company representative plans to follow up, at a later date, to fully evaluate the patient's scs system.

Manufacturer Narrative

The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on (b)(6) 2017.

Event Description

Additional information received identified the patient's implantable pulse generator was replaced.Stimulation therapy was reportedly restored postoperatively.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9821782
• MDR Text Key: 183043709
• Report Number: 1627487-2020-02688
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2020

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: 02/08/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 5844654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 05/26/2020; 10/06/2020
• Supplement Dates FDA Received: 06/15/2020; 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487/06/02/2017/001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75