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

Model Number 3343

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2014

Event Type  Injury  

Event Description

The pt was originally implanted with two model 3343 extensions from the same lot.It was reported one of the pt's extensions was explanted and replaced.No additional information was provided regarding the reason for product explant.The pt reportedly has effective stimulation postoperative.

Manufacturer Narrative

Udi (di): (b)(4).Sjm has limited information 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 EXTERNSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: logan farmer ; 6901 preston rd.; plano, TX 75024 ; 9725269611
• MDR Report Key: 4234509
• MDR Text Key: 16303566
• Report Number: 1627487-2014-08397
• 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: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2011
• Device Model Number: 3343
• Device Lot Number: 2798831
• Other Device ID Number: 05414734402293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2009
• 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: IMPLANT DATE:; IMPLANT DATE:; SCS ANCHOR: MODEL 1194 (X2); IMPLANT DATE:; SCS EXTENSION: MODEL 3342 (X2); IMPLANT DATE:; SCS IPG: MODEL 3688; SCS LEAD: MODEL 3146 (X2)
• Patient Outcome(s): Other
• Patient Age: 84 YR