MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

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

Patient Problems Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930); Pocket Erosion (2013); Post Operative Wound Infection (2446); Post Traumatic Wound Infection (2447)

Event Date 04/27/2019

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.Please note that this date is based off the date that the article was accepted for publication as the event dates were not provided in the published literature.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: (b)(4); product id: neu_ins_stimulator, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown.Carlson, jd., palmer, m., hoefer, a., cox, e., mcleod, p., mark, j., aldred, j.Deep brain stimulation generator replacement in end stage parkinson's disease.World neurosurg.2019.Doi: 10.1016/j.Wneu.2019.04.233.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: a retrospective analysis of all dbs procedures (n=446) for parkinson¿s disease spanning 20 years in a single institution was performed.The focus was on generator replacement procedure performed in end-stage parkinson¿s disease.Infections related to dbs surgery were evaluated.Results perioperative infections (<(><<)> 90 days) after generator replacements occurred in 0.6% of 172 cases, and 2.5% of 232 primary lead implantation.Delayed infections (> 90 days) occurred in 2.7% of all cases.Generator replacement was performed in 11 end-stage parkinson¿s disease patients.None of these patients developed perioperative or delayed infections, and none were readmitted for medical or surgical complications.Conclusion dbs generator replacement surgery is low risk, even in patients who have end-stage parkinson¿s disease.Reported events: 1 patient experienced an implantable neurostimulator (ins) infection within 90 days of device replacement.An infection was defined as purulent discharge from a wound that required surgical treatment.6 patients experienced a lead infection within 90 days of primary lead implant.An infection was defined as purulent discharge from a wound that required surgical treatment.6 patients experienced a delayed ins infection more than 90 days after device replacement.The authors stated that delayed infections occurred on average 7.6 months after a previous operation and were largely spontaneous but were related to erosion or trauma in 3 cases.It was not made clear whether erosion/trauma occurred.An infection was defined as purulent discharge from a wound that required surgical treatment.5 patients experienced a delayed lead infection more than 90 days of primary lead implant.The authors stated that delayed infections occurred on average 7.6 months after a previous operation and were largely spontaneous but were related to erosion or trauma in 3 cases.It was not made clear whether erosion/trauma occurred.An infection was defined as purulent discharge from a wound that required surgical treatment.An unknown number of superficial non-draining infections that were treated and resolved with oral antibiotics occurred in the authors cohort but were excluded from the study analysis.All patients were implanted with 3387 or 3389 model leads and 7426, 7428, 27601, 37602, 37603, or 37612 model neurostimulators.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8729605
• MDR Text Key: 149054725
• Report Number: 3007566237-2019-01368
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2019

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 Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/24/2019
• 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): Other; Required Intervention
• Patient Age: 67 YR