MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA; SCS LEAD

Model Number 3228

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

Patient Problems Fall (1848); Staphylococcus Aureus (2058); Post Operative Wound Infection (2446)

Event Date 02/06/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report: 1627487-2014-25158.It was reported the pt's scs system was explanted due to a staph infection at the lead and the ipg site.The pt was hospitalized and treated with oral and iv antibiotics.It was also reported the pt experienced a fall a month ago which the physician attributes the staph infection to the wounds resulting from the fall.The physician also noted yellow mucus in the ipg pocket.F/u revealed, the pt was released from the hospital and is "doing well.".

Manufacturer Narrative

Method: the device history and sterilization records were reviewed.Results: review of the dhr found a nonconformance related to the product lot.However, the individual affected device was replaced and all devices within the lot met acceptance criteria.Therefore, the dhr anomaly is not related to the alleged device complaint.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: PENTA
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 3697151
• MDR Text Key: 15126282
• Report Number: 1627487-2014-25159
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/07/2014

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: 11/01/2014
• Device Model Number: 3228
• Device Lot Number: 3861967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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: 64 YR