MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37702

Device Problems Material Protrusion/Extrusion (2979); Positioning Problem (3009)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2017

Event Type  Injury  

Manufacturer Narrative

Foreign: the country of origin is unknown; however, the patient was enrolled in a clinical study that was being conducted in (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via a manufacturer representative as part of a clinical study regarding a patient implanted with a neurostimulator.It was reported that the patient was admitted to the hospital due to the fact that the corner of the stimulator started to protrude under the skin.There was no wound, infection, or any severe problem.The stimulator was repositioned from the back to the front.It was noted that the leads were in a good position, the system was still intact, and the system worked perfectly.The problem was resolved without any complications and the patient recovered completely.The event was noted to have a causal relationship to the investigational device.

Manufacturer Narrative

Information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 7684528
• MDR Text Key: 113869003
• Report Number: 3007566237-2018-02078
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention