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

Model Number 3662

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer report number 1627487-2019-08869.Related manufacturer report number 1627487-2019-08870.It was reported that post implant procedure, impedance issue was observed on several contacts.Patient had reflex sympathetic dystrophy.A revision procedure occurred on (b)(6) 2019 to revise the leads upon which during the procedure the leads were stuck to the implantable pulse generator.The screw of the lead was difficult to remove.Physician used a new screw however it was unsuccessful.Device therapy was turned off.Patient was being treated with medicine to help resolve the pain.No further information is available at this time.

Event Description

Related manufacturer report number 1627487-2019-08869.Related manufacturer report number 1627487-2019-08870.New information received states that both leads remains implanted and the issue has not been resolved.No further information is available at this time.

Event Description

Related manufacturer report number 1627487-2019-08869.Related manufacturer report number 1627487-2019-08870.New information received states that the device was explanted on (b)(6) 2019.There were no complications during the procedure.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

The reported impedance issue was not confirmed.Analysis of the returned ipg found it communicated with all lab utilities and passed all functional testing; once the device was placed back into therapy mode.As received, the device was in service app mode due to repeated resets that occurred during the explant procedure.The returned device exhibited normal device characteristics during analysis.However, it was noted that, as received, both setscrews in the ipg header were not properly oriented and/or threaded into their respective connector blocks.This would be consistent with the leads not being properly secured in the header which could cause impedance issues.There is sufficient information in the dfu on how to connect a lead or lead extension to the ipg.

• 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: 8875968
• MDR Text Key: 153737553
• Report Number: 1627487-2019-08867
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/30/2020

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: 01/02/2021
• Device Model Number: 3662
• Device Lot Number: 6788128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 08/14/2019; 08/30/2019; 10/14/2019; 12/16/2019; 01/21/2020
• Supplement Dates FDA Received: 08/30/2019; 09/13/2019; 10/18/2019; 12/19/2019; 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS LEAD X2
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 55