MAUDE Adverse Event Report: ST. JUDE MEDICAL, NEUROMODULATION LAMITRODE TRIPOLE 16C; SCS LEAD

Model Number 3214

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Inadequate Pain Relief (2388)

Event Date 04/25/2014

Event Type  Injury  

Event Description

The patient reported the physician stated the leads appear to be in the muscle outside the spine.Additionally, the physician advised the patient to turn off stimulation.In turn, the patient noticed the nausea she was experiencing subsided when she turned stimulation off.It is unknown if the nausea is related to the scs system.The patient may to undergo surgical intervention to address the issue at a later date.

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: LAMITRODE TRIPOLE 16C
• 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: 3848565
• MDR Text Key: 4660323
• Report Number: 1627487-2014-25387
• 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: 04/25/2014

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: 07/01/2009
• Device Model Number: 3214
• Device Lot Number: 85316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2007
• 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: 3716
• Patient Outcome(s): Other
• Patient Age: 60 YR