MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B

Model Number	6170
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided on the final report.During processing of this incident, attempts were made to obtain complete device information.Date of the event is estimated.
Event or Problem Description
Related manufacturer report number: 1627487-2020-22588.It was reported that patient experienced a recent fall and had loss of effective stimulation.Lead fracture and high impedance was confirmed intraoperatively via trial cable and external pulse generator.Left lead was explanted, and a new lead was implanted however it is unknown which lead is the left lead therefore both leads are being reported.Impedances were checked post procedure and all values were within normal optimal range and effective therapy was resumed.Patient was stable.
Additional Manufacturer Narrative
Correction: upon review, the lead should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
• Common Device Name: DBS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10292344
• Report Number: 1627487-2020-22932
• Device Sequence Number: 11031000
• Product Code: MHY
• UDI-Device Identifier: 05415067020642
• UDI-Public: 05415067020642
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 02/23/2021
• Device Model Number: 6170
• Device Catalogue Number: 6178
• Device Lot Number: 6848323
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/13/2020
• 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: DBS LEAD
• Outcome Attributed to Adverse Event: Other