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

Model Number 3228

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Numbness (2415)

Event Date 08/05/2021

Event Type  Injury  

Event Description

It was reported that following the permanent scs, while in pacu, the patient experienced numbness in their right leg.The patient also reported left leg hypersensitivity to touch.It was determined that the patient has bad spinal stenosis and that the lead was causing the cord compression.As a result, the system was explanted on (b)(6) 2021 to resolve the issue.

Manufacturer Narrative

A patient outcome issue was reported to abbott.Following a permanent scs, while in pacu, the patient experienced numbness in their right leg.The patient also reported left leg hypersensitivity to touch.It was determined that the patient has bad spinal stenosis and that the lead was causing the cord compression.As a result, the system was explanted to resolve the issue.No implanted devices were returned for evaluation.The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS PADDLE LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 12378119
• MDR Text Key: 268490440
• Report Number: 3006705815-2021-04240
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: A000109238
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 109