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

Model Number MN10450-90A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided when the evaluation is completed.

Event Description

Related mfr reports: 1627487-2020-23118, 1627487-2020-23120 and 1627487-2020-23121.It was reported the patient went to the er six days after being implanted with the drg system due to pain from the surgery.The patient was admitted to the hospital for one week and administered medication for his pain.The procedural pain is better now, and there was no sign of infection.The patient's stimulator is on with no further issues.

Event Description

Related mfr reports: 1627487-2020-23118, 1627487-2020-23120 and 1627487-2020-23121.

Manufacturer Narrative

The patient's stimulator remains implanted and providing therapy.All information pertaining to this event has been reviewed and no further action is required at this time.

• 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: 10317082
• MDR Text Key: 200193815
• Report Number: 1627487-2020-23119
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027160
• UDI-Public: 05415067027160
• 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: 07/29/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Model Number: MN10450-90A
• Device Catalogue Number: MN10450-90A
• Device Lot Number: 6934593
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 07/25/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL MN10450-90A, DRG LEAD.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 46 YR
• Patient Weight: 54