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); Pain (1994); Seroma (2069)

Event Date 09/11/2017

Event Type  Injury  

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

It was reported patient was having pain near the lead incision site in her upper back.As a result, the patient was admitted to the hospital with fever on (b)(6) 2017.Ct scan was inconclusive.Since there was fluid present in the patient's upper back, a ct guided biopsy was performed.Cultures were taken and tested negative for infection.The lead and ipg sites were healing appropriately without drainage or swelling.Patient was released from the hospital on (b)(6) 2017 with iv antibiotics for six weeks.Patient was readmitted to hospital (b)(6) 2017 for increased pain, and the hospital drained a fluid pocket near the lead site.Patient states pain had decreased, and there were no signs of neuro deficits.Patient is awaiting appointment with physician to determine the next course of action.

Event Description

Follow up information identified the patient¿s issue is still unresolved and patient continues to be hospitalized in long term care, the patient is awaiting a consultation with physician to possibly perform an scs system explant in the future.

• 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: 6912907
• MDR Text Key: 88103296
• Report Number: 1627487-2017-05632
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2019
• Device Model Number: 3228
• Device Lot Number: 5903174
• Other Device ID Number: 05415067017253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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: 74 YR