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 Abscess (1690); Sepsis (2067)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).If the product is returned, it will not be analyzed as the complaint of infection can not be confirmed via laboratory testing.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.

Event Description

Device 4 of 4.Reference mfr report numbers: 3006705815-2016-00057, 1627487-2016-00665, 1627487-2016-00795.Device 3 and 4 were added to address the leads.Note: as it is unknown which devices were explanted, all are being reported.It was reported one of the patient's system was explanted.The patient is currently being treated with iv antibiotics.

Event Description

Device 4 of 4.Reference report numbers 3006705815-2016-00057, 1627487-2016-00665, 1627487-2016-00795.It was determined only one ipg was explanted on (b)(6) 2016 (device 1).Both of the leads were explanted (devices 3 & 4).Device 2 remains implanted.

• 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: 5447919
• MDR Text Key: 38582727
• Report Number: 1627487-2016-00797
• 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,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 3228
• Device Lot Number: 5009653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2015
• 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): Other
• Patient Age: 43 YR