MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG SLIM TIP LEAD

Model Number MN10450-90A

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2020

Event Type  Injury  

Event Description

Related mfr report: 1627487-2020-22435.It was reported during the patient's removal of the left t6 placement lead (reference mfr reports: 1627487-2020-21821 and 1627487-2020-21822), the lead fractured/broke inside the epidural space.Reportedly, all four contacts broke off and were left in the patient.No adverse consequences for the patient occurred, and there's no further intervention planned at this time.

Event Description

Related mfr report: 1627487-2020-22435.

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: KIT IMPLANTABLE SLIM TIP LEAD, 90CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10224865
• MDR Text Key: 197333173
• Report Number: 1627487-2020-22434
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025548
• UDI-Public: 05415067025548
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2019
• Device Model Number: MN10450-90A
• Device Catalogue Number: MN10450-90A
• Device Lot Number: AB2337
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL MN10450-90A, DRG LEAD; MODEL MN10450-90A, DRG LEAD
• Patient Outcome(s): Other
• Patient Weight: 68