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

Model Number 3228

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

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Post Operative Wound Infection (2446)

Event Date 04/06/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report #: 1627487-2014-01275.The patient reported is experiencing music spasms in his back with stimulation turned off.The pain was reportedly worse with stimulation on.Subsequently, the patient stated he was hospitalized and the scs system explanted on (b)(6) 2014 due to infection.

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 reworked 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 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.

• Brand Name: PENTA
• Type of Device: SCS LED
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: melissa nkematu ; 6901 preston rd.; plano, TX 75024 ; 9723092520
• MDR Report Key: 3799354
• MDR Text Key: 4479314
• Report Number: 1627487-2014-01274
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: 3228
• Device Lot Number: 4407195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 39 YR