MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS PADDLE LEAD

Model Number 3228

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer report number 1627487-2020-23602.It was reported that the patient's lead had disconnected from the ipg, causing the patient to be unable to place the ipg in mri mode.In turn, surgical intervention was undertaken on an unknown date wherein the ipg was explanted and replaced, resolving the issue.

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

B5 - corrected event details to reflect reason for ipg replacement.

Event Description

Clarification received that the lead disconnection was the main issue, ipg was not mri compatible.Physician replaced ipg so patient is able to get mris.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS PADDLE LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10368295
• MDR Text Key: 201716797
• Report Number: 1627487-2020-23603
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 3228
• Device Lot Number: 3869132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3688, SCS IPG; 3688, SCS IPG.
• Patient Outcome(s): Other
• Patient Weight: 136