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

Model Number 97715

Device Problems Energy Output Problem (1431); Overheating of Device (1437); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)

Event Date 03/17/2022

Event Type  malfunction  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for back problems/pain.It was reported that the patient has a lot of trouble with the anchors of the subcutaneous leads which are also very superficial.When the patient increases the stimulation for the back pain, she gets burning pain at the point of the anchors, also when sitting against the railing.The location of the leads were unchanged, x-ray confirmed this.It was noted that it was unclear whether the burning sensation was coming from the anchors or the area around the anchors.The device programs were: program a1 legs1 + 2- and 3+(9.6); a2 left lower back = 8-/10+/(1.9); a3 position lower lead 12-/15+ (3.6).Additional information was received reporting that no diagnostics/troubleshooting was performed.The cause was irritation of the anchors and overstimulation on the leads.No action was taken.The event was not resolved.

Manufacturer Narrative

Concomitant medical products: product id: 3888, lot#: unknown, product type: lead, product id: 3888, lot#: unknown, product type: lead.Other relevant device(s) are: product id: 3888, serial/lot #: unknown, product id: 3888, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13929281
• MDR Text Key: 288690528
• Report Number: 2182207-2022-00520
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female