MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 60 CM; SCS LEAD

Model Number 3166

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

Patient Problem Skin Erosion (2075)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Event and therapy date is estimated.Explant date is unknown.Further information requested but not available.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Event Description

Manufacturer report number:1627487-2020-04521, 1627487-2020-04522, 1627487-2020-04523.It was reported that the patient¿s remaining part of the lead eroded through patient¿s scalp (reference mfr # 1627487-2020-04443, 1627487-2020-04444, 1627487-2020-04446,1627487-2020-04450 for partial lead explant).As such, the remaining portion of the lead was removed four to six months ago on unknown date.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 60 CM
• Type of Device: SCS LEAD
• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10045368
• MDR Text Key: 190600176
• Report Number: 1627487-2020-04519
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734401661
• UDI-Public: 05414734401661
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 3166
• Device Catalogue Number: 3166
• Device Lot Number: 4391096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2013
• 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
• Patient Outcome(s): Other