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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
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.
 
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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 Key8729605
MDR Text Key149054725
Report Number3007566237-2019-01368
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960009
Number of Events Reported1
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 NumberNEU_INS_STIMULATOR
Device Catalogue NumberNEU_INS_STIMULATOR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/29/2019
Initial Date FDA Received06/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age67 YR
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