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 Problems Staphylococcus Aureus (2058); Inadequate Pain Relief (2388); Post Operative Wound Infection (2446)

Event Date 02/18/2015

Event Type  Injury  

Manufacturer Narrative

The product was not analyzed as the complaint of infection could not be confirmed via laboratory testing.(b)(4).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.(b)(4).

Event Description

Device 2 of 2.Reference mfr report: 1627487-2016-00826.It was reported the patient underwent surgical intervention where her entire scs system was removed.The patient indicated the stimulation did not help her crps left foot pain.She also experienced persistent right side back pain and vomiting since implant.Patient reported after her system was explanted on (b)(6) 2015, she was diagnosed with an infection at the lead incision site on (b)(6) 2015.Patient was treated with keflex.The patient was treated in the er on (b)(6) 2015, due to increased pain at the incision site.She was diagnosed with a spinal abscess.The incision was opened by the er physician and drained and she was given stronger antibiotics.On (b)(6) 2015 patient was seen by explanting physician and told she needed surgery on (b)(6) 2015 to open wound and clean it out.After surgery, the patient remained hospitalized until (b)(6) 2015.Patient stated her condition did not improve so she went back to er on (b)(6) 2015, and diagnosed with (b)(6) and admitted to the hospital.Patient stated she had a picc line for four weeks for iv antibiotics plus vancomycin.A ct and an mri showed positive for abscess and a gi workup was positive for severe esophagitis and gastritis.Patient was sent for rehab from (b)(6) 2015 to (b)(6) 2015 and stated she contracted clostridium difficile from the rehab facility.

• 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: 5449157
• MDR Text Key: 38629583
• Report Number: 1627487-2016-00827
• 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: 01/27/2016

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: 02/28/2015
• Device Model Number: 3228
• Device Lot Number: 3941570
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2013
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 63 YR