MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXCLAIM LEAD, 60 CM; SCS PADDLE LEAD

Model Number	3224
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.
Event or Problem Description
It was reported during a routine reprogramming session diagnostics indicated high impedance readings on all contacts.X-ray imaging showed the lead to have migrated out of the epidural space.Surgical intervention may take place at a later date to address the lead.
Event or Problem Description
Additional information received indicated the patient underwent surgical intervention wherein the system was explanted and replaced to address the issue.
Additional Manufacturer Narrative
Corrected data in section h: device code 1395 reported in the initial report was change from to 4003 due to further review.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 event could not be conclusively determined.

• Brand Name: EXCLAIM LEAD, 60 CM
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10575244
• Report Number: 1627487-2020-31818
• Device Sequence Number: 3138827
• Product Code: LGW
• UDI-Device Identifier: 05414734401876
• UDI-Public: 05414734401876
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2020

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: 12/28/2015
• Device Model Number: 3224
• Device Catalogue Number: 3224
• Device Lot Number: 4388856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/06/2020; 11/16/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/26/2020; 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 125