MAUDE Adverse Event Report: ST. JUDE MEDICAL PENTA 3MM LEAD; SPINAL CORD STIMULATOR 16 CHANNEL

Model Number 3228

Device Problem Insufficient Information (3190)

Patient Problems Neurological Deficit/Dysfunction (1982); Complaint, Ill-Defined (2331)

Event Date 07/24/2015

Event Type  Injury  

Event Description

Upon surgical placement of st.Jude medical protege mri ipg and penta 3mm lead, the patient experienced lack of motor and sensory function of the lower extremities confirmed with changes during neuromonitoring.The patient was then re-anesthetized and a laminectomy performed with improved result.Reason for use: chronic back pain.Event abated after use: yes.

• Brand Name: PENTA 3MM LEAD
• Type of Device: SPINAL CORD STIMULATOR 16 CHANNEL
• Manufacturer (Section D): ST. JUDE MEDICAL; plano TX 75024
• MDR Report Key: 4956562
• MDR Text Key: 6195300
• Report Number: MW5044945
• Device Sequence Number: 2
• Product Code: GZB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2016
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 4500809
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR