MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXCLAIM 8; SCS

Model Number 3224

Device Problem High impedance (1291)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/29/2014

Event Type  Injury  

Event Description

The patient has 2 leads (from the same lot) implanted as part of her scs system.It was reported the patient could not feel stimulation coverage.Diagnostic testing revealed high impedance reading on all lead contacts.Subsequently, the patient underwent surgical intervention on (b)(6) 2014, where her leads were explanted and replaced with new ones.The patient reported adequate stimulation coverage postoperative.

Manufacturer Narrative

Sjm has limited information related to the patient's medical history an 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: EXCLAIM 8
• Type of Device: SCS
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: jennifer shepard ; 6901 preston rd.; plano, TX 75024 ; 9725264657
• MDR Report Key: 3931887
• MDR Text Key: 4578865
• Report Number: 1627487-2014-23418
• 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: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Model Number: 3224
• Device Lot Number: 3608316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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 EXTENSION: MODEL 3383 (2); IMPLANT DATE:; IMPLANT DATE:; SCS IPG: MODEL 3788
• Patient Outcome(s): Other