MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44 LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number	3262
Medical Device Problem Codes	High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with the investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference numbers: 1627487-2019-06230, 1627487-2019-06231.It was reported that the patient experienced ineffective stimulation.The patient reported that the system was not providing adequate relief regardless of therapy strength or program.Impedances were checked and all contacts except one were high.The one contact that was not high showed low impedance.The patient may undergo surgical intervention.
Event or Problem Description
Related manufacturer reference number: 1627487-2019-06230, 1627487-2019-06231, 3006705815-2019-02296.Follow up information received that the patient underwent surgery in which two leads and the ipg were replaced.Patient has effective therapy post operation.

• Brand Name: LAMITRODE 44 LEAD KIT, 90CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 8651334
• Report Number: 1627487-2019-06229
• Device Sequence Number: 263363
• Product Code: LGW
• UDI-Device Identifier: 05414734402132
• UDI-Public: 05414734402132
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: 11/28/2015
• Device Model Number: 3262
• Device Lot Number: 4354136
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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 3219, SCS LEAD; MODEL 3262, SCS LEAD
• Outcome Attributed to Adverse Event: Other