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 01/22/2020

Event Type  Injury  

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 02 june 2017.

Event Description

It was reported the patient has not been able to communicate with the scs ipg since she underwent a shoulder surgery on (b)(6) 2020.Reportedly, the system's surgery mode was not turned on prior to the procedure.A company representative met with the patient but was unable to resolve the issue with troubleshooting.Surgical intervention to replace the patient's scs ipg may be necessary.

Manufacturer Narrative

An inoperable implant was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery may have been used.The implant was not returned for analysis.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.Based on the information received, the cause of the reported incident is consistent with user error.

Event Description

Additional information received identified the patient's scs system generator was replaced.The procedure was reportedly without complications and stimulation therapy was restored postoperatively.

Manufacturer Narrative

E1 - initial reporter - corrected physician information.

• 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: 9863085
• MDR Text Key: 184372062
• Report Number: 1627487-2020-03071
• 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,Followup,Followup
• Report Date: 09/16/2021

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: 11/06/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 6185151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 05/19/2020; 06/01/2020; 06/25/2021; 08/30/2021; 09/16/2021
• Supplement Dates FDA Received: 05/28/2020; 06/05/2020; 07/09/2021; 09/13/2021; 09/16/2021
• 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: 73