MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/4MM, 90 CM; PERCUTANEOUS LEAD

Model Number	3149
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Inadequate Pain Relief (2388)
Date of Event	11/19/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number 1627487-2020-22528; related manufacturer reference number 1627487-2020-22529; related manufacturer reference number 1627487-2020-22531.It was reported the patient stated he experienced uncomfortable stimulation.Patient stated physician implanted leads in a different location than the location used for the trial and he feels pain.Patient said he had a lead revision procedure (date not provided), but the issue persisted.Patient desires to have the system removed.An abbott representative contacted the patient and indicated the system appears to be nonfunctional and that the patient¿s physician does not plan to remove the system at this time due to patient¿s health conditions.Patient plans to consult with another physician.
Event or Problem Description
Related manufacturer reference number 1627487-2020-32278 additional information received identified that patient stopped the ipg because of the uncomfortable stimulation and recharge burden.The ipg was deemed inoperable and patient lost stimulation.As a result, surgical intervention was undertaken on (b)(6) 2020, wherein the ipg was explanted and replaced.Effective therapy was restored post operatively.
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.
Event or Problem Description
Additional information received identified that patient stopped charging the ipg because of the uncomfortable stimulation and recharge burden.The ipg was deemed inoperable and patient lost stimulation.As a result, surgical intervention was undertaken on (b)(6) 2020 wherein the ipg was explanted and replaced.Effective therapy was restored post operatively.
Additional Manufacturer Narrative
Corrected data.B5 - describe event or problem.

• Brand Name: QUATTRODE LEAD, 3/4MM, 90 CM
• Common Device Name: PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10242603
• Report Number: 1627487-2020-22527
• Device Sequence Number: 2603521
• Product Code: LGW
• UDI-Device Identifier: 05414734401593
• UDI-Public: 05414734401593
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/15/2020

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: 06/28/2013
• Device Model Number: 3149
• Device Catalogue Number: 3149
• Device Lot Number: 3406153
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/18/2020; 09/21/2020; 10/12/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/21/2020; 10/09/2020; 10/15/2020
• 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 3169, SCS LEADS (2); MODEL 3266, SCS LEAD; MODEL 3788, SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 63