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

Model Number 3228

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 06/10/2014

Event Type  Injury  

Event Description

It was reported since the patient's implant of her penta lead, she is experiencing left sided occipital neuralgia.The patient has effective stimulation on the right side.However, she is without left sided coverage.The patient's pain pattern is her bilateral neck, shoulder, arm, and hand.Surgical intervention is pending to address the reported issue.

Manufacturer Narrative

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 LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 3949486
• MDR Text Key: 4643464
• Report Number: 1627487-2014-23441
• 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: 06/10/2014

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: 02/01/2016
• Device Model Number: 3228
• Device Lot Number: 4491447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: IMPLANT DATE:; SCS IPG, MODEL 3788; IMPLANT DATE:; IMPLANT DATE:; SCS LEAD, MODEL 3186 (2); SCS IPG, MODEL 3788
• Patient Outcome(s): Other
• Patient Age: 66 YR