MAUDE Adverse Event Report: ST. JUDE MEDICAL -NEUROMODULATION PENTA; SCS LEAD

Model Number 3228

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

Patient Problems Abscess (1690); Paraplegia (2448)

Event Date 05/01/2014

Event Type  Injury  

Event Description

The pt (poland) was implanted with an scs system which included a surgical lead.It was reported during the procedure, the physician performed a right hemilaminectomy at level t1-t11 and positioned the lead almost midline.Effective stimulation was achieved postoperatively.Approximately 4-6 weeks after the procedure, the pt reported to the physician with bilateral motor loss of the lower extremities.An epidural abscess was diagnosed.The physician immediately proceeded with surgical intervention to explant the entire system.Liquid from the abscess was sent to the lab and antibiotics were applied.Lab results were not disclosed to the mfr.An additional surgery was performed on (b)(6) 2014 to irrigate the wound with antibiotics.The pt's legs remained non-functional.Follow up on this matter revealed sensory function has returned to knee level; however, the pt's legs still do not function.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.

• Brand Name: PENTA
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL -NEUROMODULATION; plano TX
• Manufacturer Contact: karin bechler ; 6901 preston rd.; plano, TX 75024 ; 9723092511
• MDR Report Key: 3850554
• MDR Text Key: 4617372
• Report Number: 1627487-2014-10119
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Model Number: 3228
• Device Lot Number: 3817037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: IMPLANT DATE:; SCS IPG: MODEL UNK
• Patient Outcome(s): Other