MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/4MM, 90 CM; PERCUTANEOUS LEAD

Model Number	3149
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/19/2020
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.
Event or Problem Description
Related manufacturer reference numbers: 1627487-2020-32027.1627487-2020-32028.1627487-2020-32030.1627487-2020-32031.1627487-2020-32033.1627487-2020-32034.It was reported that patient experienced ineffective therapy on the left side.Diagnostic testing revealed high impedance.Reprogramming did not resolve the issue.Surgery may occur to address the issue.Which devices are related to the issue is unknown, so all suspected devices are being reported.
Additional Manufacturer Narrative
Correction: manufacturer report number 1627487-2020-32029 should not have been submitted as a medical device report (mdr) as there is no indication the device caused or contributed to the issue.

• Brand Name: QUATTRODE LEAD, 3/4MM, 90 CM
• Common Device Name: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10632783
• Report Number: 1627487-2020-32029
• Device Sequence Number: 11667718
• Product Code: LGW
• UDI-Device Identifier: 05414734401593
• UDI-Public: 05414734401593
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2020

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: 11/28/2014
• Device Model Number: 3149
• Device Catalogue Number: 3149
• Device Lot Number: 3867350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/11/2020
• 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: PERCUTANEOUS LEAD (X3); SCS EXTENSION (X2); SCS IPG; PERCUTANEOUS LEAD (X3); SCS EXTENSION (X2); SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Weight: 66