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

Model Number 3660ANS

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/25/2019

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

Event Description

It was reported the patient was unable to establish a connection between the ipg and the patient controller (pc).Remote troubleshooting was unsuccessful in restoring access.The patient stated that it began after they underwent a surgical procedure and did not place the device into surgery mode.In turn, the patient may undergo surgical intervention as the next course of action.

Manufacturer Narrative

An inoperable pulse generator was reported to abbott.The system was not set to surgery mode while the patient underwent an unrelated surgery where electro-cautery was used.A review of documentation supplied with the implant states that electro-surgery devices should not be used in close proximity to an implanted system.The results of the investigation are inconclusive since the device was not returned for analysis.Actions have been taken to prevent reoccurrence.

Event Description

It was reported that the patient underwent surgical intervention wherein the scs ipg was explanted and replaced to address the issue.Effective therapy was reportedly restored post-operatively.

Manufacturer Narrative

The reported issue ¿ipg would not connect to pc¿ was confirmed.The inability to communicate between the clinicians programmer and the implantable pulse generator was due to the device entering the service application state.This issue can occur when the device is exposed to an external energy source outside the device handling and storage requirements.Once the device has entered into the service application state, the cp will be inhibited from programming the device into the therapy application state.The report stated that the patient had an unrelated surgery.

• Brand Name: PROCLAIM 5 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: 9192299
• MDR Text Key: 162332371
• Report Number: 1627487-2019-11613
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: 05415067020192
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2019
• Device Model Number: 3660ANS
• Device Catalogue Number: 3660
• Device Lot Number: 5911010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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 Age: 40 YR