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

Model Number	3224
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's weight was unable to be obtained.The results/method and conclusion codes along with the investigation results will be provided in the final report.
Event or Problem Description
Device 1 of 2; reference mfr.Report#: 1627487-2020-22955.It was reported the high impedance was found on both of the patient's lead contacts.As a result, both of the patient's leads were explanted and replaced to address their issue.
Event or Problem Description
Device 1 of 2 reference mfr.Report#: 1627487-2020-22955.
Additional Manufacturer Narrative
The reported event of high impedance was not confirmed.As received the paddle length was complete but cut into two pieces.It passed continuity testing on all channels.No root cause was identified for the reported event.

• Brand Name: EXCLAIM LEAD, 60 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10292816
• Report Number: 1627487-2020-22954
• Device Sequence Number: 16412412
• Product Code: LGW
• UDI-Device Identifier: 05414734406178
• UDI-Public: 05414734406178
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 3224
• Device Catalogue Number: 3224
• Device Lot Number: 5043584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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: 3286
• Outcome Attributed to Adverse Event: Other