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 Abscess (1690); Unspecified Infection (1930)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 3006705815-2019-01982.1627487-2019-06214.1627487-2019-06215.It was reported that the patient developed a suture abscess and was hospitalized.As a result, the patient had an incision and drainage procedure at the lead site on (b)(6) 2019 and was prescribed antibiotics.

Event Description

Related manufacturer reference numbers: 3006705815-2019-01982 1627487-2019-06214 1627487-2019-06215.

Manufacturer Narrative

Corrected information: infection was added as a patient code, which was not included in the initial report.

Event Description

Related manufacturer reference numbers: 3006705815-2019-01982; 1627487-2019-06214; 1627487-2019-06215.Additional information was received that patient's infection did not resolve.As a result, surgical intervention was undertaken wherein the system was explanted.

• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8654089
• MDR Text Key: 146503822
• Report Number: 3006705815-2019-01981
• Device Sequence Number: 1
• Product Code: LGW
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2020
• Device Model Number: 3186
• Device Lot Number: A000069978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2018
• 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: 1192, SCS ANCHOR (2); MODEL: 3186, SCS LEAD
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 91