MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LEGACY MDT POCKET ADAPTER, 2303; LEAD EXTENSION

Model Number	2303
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
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
Reference mfr.Report: 1627487-2019-11085.It was reported patient had low impedances from the time he had a fall approximately in (b)(6) 2019.It was thought that the issue had resolved but it was not and recently during programming approximately on (b)(6) 2019 the issue was confirmed to still be present.To address this issue the lead extensions were replaced.However, still the low impedance issue persisted but effective therapy was achieved 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.

• Brand Name: LEGACY MDT POCKET ADAPTER, 2303
• Common Device Name: LEAD EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 9155885
• Report Number: 1627487-2019-11070
• Device Sequence Number: 19278392
• Product Code: GZB
• UDI-Device Identifier: 05415067029430
• UDI-Public: 05415067029430
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/08/2019

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: 01/30/2020
• Device Model Number: 2303
• Device Lot Number: 6290302
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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 2303 LEAD EXTENSION
• Outcome Attributed to Adverse Event: Other