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

Model Number 3219

Device Problems Migration or Expulsion of Device (1395); Device Stops Intermittently (1599); Impedance Problem (2950)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 05/20/2014

Event Type  Injury  

Event Description

It was reported the pt experienced intermittent overstimulation from her scs system.It was also reported the pt feels overstimulation sensations in her normal stimulation areas for shoulder/arm pain; cervical placement.Additionally, the pt reported overstimulation in her legs.The sjm representative confirmed the issue and reprogramming was unable to resolve it.Diagnostic testing revealed invalid impedance readings on multiple lead contacts.Follow-up info revealed x-rays were taken and revealed the lead wires appeared to be firm on the right side, however, the bottom of the lead had migrated towards the left.The pt plans to undergo surgical intervention at a future date to address the reported issues.

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 16
• 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: 3919116
• MDR Text Key: 4665100
• Report Number: 1627487-2014-23409
• 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: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2011
• Device Model Number: 3219
• Device Lot Number: 2782827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• 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 IPG: MODEL 3788; IMPLANTED:
• Patient Outcome(s): Other
• Patient Age: 36 YR