MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16C

Model Number 3214

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Muscle Spasm(s) (1966)

Event Date 12/09/2013

Event Type  Injury  

Event Description

It was reported the pt experienced spasms in her leg when she turns her stimulation up.Reprogramming was able to resolve this issue.However, the issue has reoccurred.The pt will meet with the sjm representative as the next course of action.

Manufacturer Narrative

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: LAMITRODE TRIPOLE 16C
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 3673949
• MDR Text Key: 4242325
• Report Number: 1627487-2014-23003
• 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: 12/09/2013

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: 3214
• Device Lot Number: 3863053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2013
• Initial Date FDA Received: 01/03/2014
• 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
• Treatment: SCS ANCHOR: MODEL 1192; IMPLANTED:; IMPLANTED:; SCS IPG: MODEL 3788
• Patient Outcome(s): Other
• Patient Age: 39 YR