MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR

Model Number NEU_INS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069); Inadequate Pain Relief (2388); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The patient reported that they had a scs ins at one point, however the ins had to be removed; pt stated that they were in a lot of pain since the device was removed.The patient reported that they were implanted maybe 18 months to two years ago.Pt stated that the ins was removed maybe 6 months after the ins was implanted.Pt stated that the first time they had to have correction surgery was because the mylar electrodes slipped down, so hcp (health care professional) said that they would anchor the system up better. pt stated that they couldn't quite get it right, so they kept meeting with the manufacturer representatives and they just couldn't get it "fixed in" and that then by that time, they found out that the device had slid down, so that was the reason why they couldn't get it tuned in. it was understood that the pt was meaning that they couldn't get the therapy adjusted properly when they went in for ins programming when the pt was saying that they "couldn't get the device tuned in". pt stated that hcp went in a second time and anchored the device, however hcp also re-opened the pocket for the ins and moved the ins around since the corner of the ins was sticking out and protruding from their skin, so hcp got that flattened out and then a couple weeks after that, they started getting the fluid build up, so they don't know if it was an infection or what was going on.Pt confirmed that the fluid build up was in the ins pocket; pt stated that they were in a lot of pain.Pt stated that the device was then put in the right spot, however they still couldn't get it tuned in and that was when they started having the fluid build up, so hcp then removed the ins.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12100775
• MDR Text Key: 259428497
• Report Number: 2182207-2021-01167
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• 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 Outcome(s): Required Intervention