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

Model Number 3228

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported following the patient's scs system implant procedure the patient had no lower body movement.A ct scan did not show any hematomas, however, there was stenosis around the lead.The patient was given the steroid decadron.Reportedly, the patient gradually regained his lower body motor functions.Follow up identified the patient's scs system was turned on, and the patient has resumed all normal neurological function in lower body.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• 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
• MDR Report Key: 5671111
• MDR Text Key: 45672108
• Report Number: 1627487-2016-02593
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 3228
• Device Lot Number: 5366676
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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: MODEL 3662, SCS IPG
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR