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

Model Number 3228

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Muscle Spasm(s) (1966)

Event Date 02/09/2014

Event Type  Injury  

Event Description

It was reported the pt is in the hospital after experiencing muscle spasms and a fall allegedly due to the scs system.Diagnostics revealed no anomalies.X-rays were ordered.The pt was advised to use lower levels and use the system less frequently.Follow-up revealed, the pt remembered having an ultrasound on her hip, back and buttocks.The pt was advised that ultrasound therapies can damage the device.The pt will contact sjm with updates on her condition.

Manufacturer Narrative

Sjm has limited information 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 road; plano, TX 75024 ; 9725264659
• MDR Report Key: 3721079
• MDR Text Key: 4334019
• Report Number: 1627487-2014-25166
• 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: 02/12/2014

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: 02/01/2013
• Device Model Number: 3228
• Device Lot Number: 3315571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• 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: SCS ANCHORS: MODEL: 1194 (X2); IMPLANT DATE:; IMPLANT DATE:; SCS IPG: MODEL: 3788
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR