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

Model Number 3214

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Shock (2072); Inadequate Pain Relief (2388)

Event Date 01/28/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-04133.It was reported the patient was experiencing shocking sensations in her stomach, and also does not feel stimulation when lying down.The patient reported the physician stated the lead was not in a correct position.In addition, the patient reported the physician was discussing moving the ipg.The reason for moving the ipg was undetermined.

Manufacturer Narrative

Sjm has limited information 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: jennifer st. clair ; 6901 preston rd.; plano, TX 75024 ; 9725264677
• MDR Report Key: 3720931
• MDR Text Key: 4233903
• Report Number: 1627487-2014-04132
• 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: 02/10/2014

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: 10/01/2010
• Device Model Number: 3214
• Device Lot Number: 174385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• 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
• Patient Outcome(s): Other
• Patient Age: 43 YR