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

Model Number	6170
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Type of Reportable Event	Serious Injury
Event or Problem Description
Related mfr report: 1627487-2019-12764.It was reported the patient was experiencing insufficient therapy from the dbs system.In follow up in the clinic, the healthcare provider performed a system impedance test and discovered high/invalid impedance on one of the lead channels.The patient's dbs system could not be reprogrammed to recapture beneficial therapy.Additional follow up identified the patient underwent surgical intervention on (b)(6) for an intraoperative measurement with external devices.The results were the same as before with the invalid impedance for the lead's channel 1.The dr.Reconnected the initial ipg with the extensions without exchanging any implanted product.Additional surgical intervention may be taken at a later date.
Event or Problem Description
Related mfr report: 1627487-2019-12764.Follow up information received identified the patient does not want to undergo further surgery for a revision of the dbs system.
Additional Manufacturer Narrative
Device history record review has determined that manufacturing completed all steps correctly and there were no errors in the production of the product.Prior to release, all released units were conforming to all applicable acceptance criteria for each level build.
Event or Problem Description
Related mfr report: 1627487-2019-12764.

• 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: 9319500
• Report Number: 1627487-2019-12765
• Device Sequence Number: 2373995
• Product Code: MHY
• UDI-Device Identifier: 05415067020635
• UDI-Public: 05415067020635
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2020

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: 08/08/2019
• Device Model Number: 6170
• Device Catalogue Number: 6170
• Device Lot Number: 6130739
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 02/19/2020; 05/14/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/19/2020; 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other