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

Model Number 3225

Device Problem Torn Material (3024)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/25/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-15672.It was reported during a spinal fusion procedure, the patient's ipg was explanted and replaced (reference mfr report: 1627487-2014-08276) and the outer tubing of the patient's leads was found to be stripped.Surgical intervention may take place at a later date.

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 LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: toi milner ; 6901 preston rd.; plano, TX 75024 ; 9723098107
• MDR Report Key: 4098597
• MDR Text Key: 17264078
• Report Number: 1627487-2014-15671
• 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: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2010
• Device Model Number: 3225
• Device Lot Number: 113532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• 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
• Treatment: SCS IPG: MODEL 3788; IMPLANT DATE:; SCS ANCHOR: MODEL 1194; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 59 YR