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

Model Number	6170
Medical Device Problem Codes	High impedance (1291); Low impedance (2285)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/30/2019
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
Device 4 of 5.Reference mfr report: 1627487-2019-03087.Reference mfr report: 1627487-2019-03088.Reference mfr report: 1627487-2019-03089.Reference mfr report: 1627487-2019-03092.It was reported the patient experienced ineffective therapy.On (b)(6) 2019 high impedance was observed on the left lead.Physician suspected poor connection between the extension and ipg.In turn, surgical intervention was undertaken on (b)(6) 2019 wherein the extension was reconnected into the ipg.During intra-op impedance check revealed high on two contacts and other contacts confirmed normal impedances.Hence, the procedure was completed.However, low impedance was observed later and the patient continues to experience ineffective therapy post operatively.
Additional Manufacturer Narrative
Concomitant medical product(s): it was inadvertently reported in the initial report both the concomitant extensions were same model 6372.The correct model numbers are 6372 and 6371.
Event or Problem Description
Device 4 of 5.Reference mfr report: 1627487-2019-03087; reference mfr report: 1627487-2019-03088; reference mfr report: 1627487-2019-03089; reference mfr report: 1627487-2019-03092.Follow-up information indicated that the patient underwent surgical intervention on (b)(6) 2019 wherein the two extensions and ipg were explanted and replaced.Nothing was done regarding the leads.Postoperatively impedances were in normal range and therapy was established.
Event or Problem Description
Device 4 of 5.Reference mfr report: 1627487-2019-03087.Reference mfr report: 1627487-2019-03088.Reference mfr report: 1627487-2019-03089.Reference mfr report: 1627487-2019-03092.

• 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: 8396392
• Report Number: 1627487-2019-03090
• Device Sequence Number: 1628814
• Product Code: MHY
• UDI-Device Identifier: 05415067020635
• UDI-Public: 05415067020635
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2019

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: 11/16/2019
• Device Model Number: 6170
• Device Catalogue Number: 6170
• Device Lot Number: 6197964
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 03/11/2019; 04/11/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/25/2019; 04/12/2019
• 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 6170, BDS LEAD; MODEL 6372 (X2), DBS EXTENSION; MODEL 6662, DBS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 70