MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXCLAIM LEAD, 90 CM; SCS LEAD

Model Number	3225
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event is estimated.The results, method and conclusion codes along with the investigation results will be provided in the final report.
Event or Problem Description
Manufacturer report reference number: 1627487-2020-24094, 1627487-2020-24096.It was reported that the patient experienced high impedance.As a result, the patient underwent surgical intervention in which the leads were explanted and replaced with one penta lead.During the procedure it was noted that the exclaim leads were visibly fractured.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EXCLAIM LEAD, 90 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10416237
• Report Number: 1627487-2020-24097
• Device Sequence Number: 11433448
• Product Code: LGW
• UDI-Device Identifier: 05415067017758
• UDI-Public: 05415067017758
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 3225
• Device Catalogue Number: 3225
• Device Lot Number: 5423683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL 3189, SCS LEAD; MODEL 3225, SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 45