MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

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

Patient Problems Fever (1858); Pain (1994); Swelling (2091)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr report#3006705815-2018-01424.It was reported that patient experienced pain and swelling at the lead incision site.Patient also reported fever, cough and upper respiratory infection which physician believes is unrelated to the scs system.Patient is prescribed prophylactic antibiotics.Blood work and urinalysis done at the emergency room (er) were unremarkable.Cultures/labs and ct were normal.A follow-up visit at the physician office reported patient had no pain and no symptoms of infection and fever subsided.Patient has satisfactory therapy and the issue has been resolved.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: seema wakdikar ; 9725268205
• MDR Report Key: 7649227
• MDR Text Key: 112692761
• Report Number: 3006705815-2018-01425
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2020
• Device Model Number: 3186
• Device Lot Number: A000053716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Date Device Manufactured: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 1192(2), SCS ANCHOR; MODEL 3660, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 35 YR