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 Fever (1858); Vomiting (2144); Post Operative Wound Infection (2446)

Event Date 10/11/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturer's evaluation: the returned 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 manufacturer report: 1627487-2016-05764.It was reported the patient presented to the emergency room on (b)(6) 2016 with fever and vomiting.The patient was diagnosed with an infection at the lead and ipg sites and subsequently explanted on (b)(6) 2016.In addition, the infection was treated with antibiotics.

Manufacturer Narrative

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 2 of 2: reference manufacturer report: 1627487-2016-05764.Follow-up revealed the infection has resolved.

• 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: 6081153
• MDR Text Key: 59278144
• Report Number: 1627487-2016-05766
• 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: 11/28/2016

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: 06/30/2018
• Device Model Number: 3228
• Device Lot Number: 5574481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2016
• 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
• Patient Age: 51 YR