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

Model Number 3662

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/12/2019

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 subsequent submission.

Event Description

It was reported that the patient underwent an unrelated surgical procedure on (b)(6) 2019, where the ipg was not put in to surgery mode.In turn, the ipg became inoperable.Troubleshooting was attempted with no success.In turn, patient may undergo surgical intervention to address the issue.

Manufacturer Narrative

A case of the ipg not connecting to patient controller after unrelated surgery was reported to abbott.After multiple attempts to troubleshoot therapy could not be restored.The results of the investigation are inconclusive since the device was not returned for analysis.All event information pertaining to this issue has been assessed and no further review or analysis is required at this time.The cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient had their ipg explanted and replaced.Effective therapy was established post op.

• 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: 8761221
• MDR Text Key: 150103873
• Report Number: 1627487-2019-07733
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2019

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: 04/27/2020
• Device Model Number: 3662
• Device Lot Number: 6421172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 08/29/2019; 09/30/2019
• Supplement Dates FDA Received: 09/09/2019; 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2018
• 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: 59