MAUDE Adverse Event Report: ST JUDE MEDICAL - NEUROMODULATION QUATTRODE; SCS LEAD

Model Number 3166

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Post Operative Wound Infection (2446)

Event Date 03/11/2014

Event Type  Injury  

Event Description

The pt has two supra-orbital and two occipital leads (off-label use) with the same lot number.It was reported the pt developed an infection behind her right ear and the side of her neck after a revision procedure on (b)(6) 2014.Revision procedure reported under mfr report: 1627487-2014-15363.Additionally, it was reported the pt experienced difficulty breathing due an allergic response from the antibiotic sutures used by the physician to close the pt.It was noted the pt is allergic to penicillin.It was also reported the pt developed a rash due to the steroids given to the pt to address her breathing issue.F/u revealed no cultures were taken and antibiotics resolved the pt's infection.Additionally, the pt's rash and breathing issue resolved.

Manufacturer Narrative

Method - the device history and sterilization records were reviewed.Results - the device history and sterilization records reviewed were found to meet specs and no anomalies related to this event were found.Conclusion - the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.Sjm has limited info 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: QUATTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: benjyna obasuyi ; 6901 preston rd.; plano, TX 75024 ; 9725264659
• MDR Report Key: 3820910
• MDR Text Key: 4497436
• Report Number: 1627487-2014-25378
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072462
• 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: 04/22/2014

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: 07/01/2015
• Device Model Number: 3166
• Device Lot Number: 4155048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS EXTENSION: MODEL 3346 (2); IMPLANT DATE:; SCS IPG: MODEL 3788; IMPLANT DATE:
• Patient Outcome(s): Other
• Patient Age: 45 YR