MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION INFINITY IPG; SCS IPG

Model Number 6662

Device Problems High impedance (1291); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided on the final report.Further information was requested but not received.

Event Description

Related manufacturer reference number: 1627487-2019-07818 & 1627487-2019-07819.It was reported that the patient experienced invalid impedances.As a result, surgical intervention was taken.During the procedure, it was noted that the extension was not fully inserted into the ipg header.The physician experienced difficulty fully inserting the extension into the header.The physician elected to leave the extension as is.An additional procedure is pending.

Event Description

Related manufacturer reference number: 1627487-2019-07818 & 1627487-2019-07819.Surgical intervention was taken on (b)(6) 2019 to replace the ipg.During the revision it was noted that the extension was broken.As a result, the extensions were both replaced.Issue has been resolved.

Manufacturer Narrative

The reported impedance issue was confirmed.Analysis of the ipg did identify bal-spring damage in port 1-8.Consistent with the report of difficulty inserting extension into this port; extension not fully inserted would be consistent with an impedance issue.

• Brand Name: INFINITY IPG
• 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: 8771555
• MDR Text Key: 150406193
• Report Number: 1627487-2019-07820
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067020260
• UDI-Public: 05415067020260
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: 6662
• Device Lot Number: 6819694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• 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 EXTENSION X 2
• Patient Outcome(s): Other