MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 30 CM; SCS LEAD

Model Number	3153
Medical Device Problem Codes	Disconnection (1171); High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Device 1 of 3; related manufacturer reference number: 1627487-2020-23247, related manufacturer reference number: 1627487-2020-23248.It was reported the patient showed high impedances on two contacts, although stimulation was effective.X-rays revealed the patient¿s left quattrode was not fully inserted into the extension.To address the issue, the physician explanted and replaced the patient¿s extension on (b)(6) 2020.After changing the extension, one impedance on the right lead remained high, and the left side showed normal impedances.Postoperatively, effective stimulation was achieved.Note: it is unknown which quattrode serial number was affected, therefore both are being reported.
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: QUATTRODE LEAD, 3/6MM, 30 CM
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10382736
• Report Number: 1627487-2020-23246
• Device Sequence Number: 2705209
• Product Code: LGW
• UDI-Device Identifier: 05414734406062
• UDI-Public: 05414734406062
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 04/28/2015
• Device Model Number: 3153
• Device Catalogue Number: 3153
• Device Lot Number: 4046671
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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 3153; MODEL 3346
• Outcome Attributed to Adverse Event: Other