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 Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.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.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the ipg was unable to establish communication with external devices.Patient did not set the ipg into surgery mode prior to an unrelated surgical procedure.A manufacturer representative confirmed the issue and the ipg deemed inoperable.Surgical intervention may be pending to address the issue.

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete explant date and event information.Further information was requested but not received.

Event Description

Further follow-up indicated that patient underwent surgical intervention, wherein the ipg was explanted on unknown date.

Manufacturer Narrative

Correction: d6b - date of explant: date of explant corrected.Correction h10: the following final investigation conclusion was inadvertently omitted from the previous report: 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 indicated that the ipg was not explanted in 2019.Surgical intervention was undertaken on (b)(6) 2023 wherein the ipg was explanted and replaced.Effective therapy was restored.

• 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: 8852008
• MDR Text Key: 152980048
• Report Number: 1627487-2019-08520
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2019
• Device Model Number: 3662
• Device Lot Number: 6130897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2017
• 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 Sex: Female
• Patient Weight: 84 KG