MAUDE Adverse Event Report: ST. JUDE MEDICAL- NEUROMODULATION DUAL EXTENSION; SCS EXTENSION

Model Number 3346

Device Problems Break (1069); Impedance Problem (2950)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330)

Event Date 02/18/2014

Event Type  Injury  

Event Description

Device 2 of 2.Reference mfr report number: 1627487-2014-23182.It was reported the patient experienced pain, a discomfort and inflammation at the extension site.Surgical intervention was undertaken on (b)(6) 2014.Diagnostic testing revealed invalid impedance readings.Visual inspection revealed a break in the model 3346 extension.The extension break occurred during the revision procedure.Subsequently, the extensions were explanted and replaced.The patient reported effective coverage postoperative.

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: DUAL EXTENSION
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL- NEUROMODULATION; 6901 preston rd.; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL- NEUROMODULATION; 6901 preston rd.; plano TX 75024
• Manufacturer Contact: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 3697046
• MDR Text Key: 4252046
• Report Number: 1627487-2014-23183
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2013
• Device Model Number: 3346
• Device Lot Number: 3365422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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: IMPLANT DATE:; IMPLANT DATE:; SCS LEAD: MODEL 3149 (2); SCS LEAD: MODEL 3186 (2); SCS EXTENSION: MODEL 3386 (2); SCS IPG: MODEL 3716; IMPLANT DATE:; SCS LEAD: MODEL 3166 (2); IMPLANT DATE:; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 66 YR