MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD

Model Number 3219

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

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Post Operative Wound Infection (2446)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturer¿s evaluation: the returned product was not analyzed as the complaint of infection could 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.(b)(4).

Event Description

Device #1 of 2: reference mfr.Report: 1627487-2015-26595.It was reported the patient was experiencing pain in the back with spasms radiating towards the ribs since implantation.The pain was present whether the system was turned on or off.The patient was evaluated in the emergency room and admitted for further care.Follow up information identified the patient underwent surgical intervention to explant the scs system on (b)(6) 2015 due to infection.The patient is currently on antibiotics for the next eight weeks.The pain and spasms were due to the infection which was located at the lead site tracking to the battery.The pain and spasms have resolved.

• Brand Name: LAMITRODE TRIPOLE 16 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: 5204607
• MDR Text Key: 30510479
• Report Number: 1627487-2015-26594
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2015

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: 12/28/2016
• Device Model Number: 3219
• Device Lot Number: 4898840
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2014
• 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 3771, SCS IPG
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR