MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number NEU_INS_STIMULATOR

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem Unspecified Infection (1930)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Other relevant device(s) are: product id: 3387, serial/lot #: unknown.Product id: 3387, serial/lot #: unknown.Product id: 3387, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: 3387, serial/lot #: unknown.Product id: neu_unknown_ext, serial/lot #: unknown.Tsuboi, t., jabarkheel, z., foote, kd., okun, ms., wagle shukla, a.Importance of the initial response to gpi deep brain stimulation in dystonia: a nine year quality of life study.Parkinsonism relat disord.2019.Doi: 10.1016/j.Parkreldis.2019.04.024.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: background: long-term efficacy of deep brain stimulation (dbs) on health-related quality-of-life (hrqol) for isolated dystonia is not well established.This study aims to determine the long-term impact of dbs on hrqol outcomes and identify clinical predictors.Methods: we retrospectively investigated 16 inherited or idiopathic isolated dystonia patients treated with bilateral globus pallidus internus dbs who were followed beyond 9 years at our center.The cohort consisted of 9 males, 7 females; 10 generalized, 6 segmental; mean (range) age at implantation, 37.0 (8¿67) years; mean follow-up duration after implantation, 10.9 (9¿13) years.We employed the unified dystonia rating scale for motor and short form health survey for hrqol assessments to monitor the change longitudinally.We analyzed the changes in motor and hrqol at 1¿2 years (short-term) and =9 years (long-term) follow-up as compared to baseline with a wilcoxon signed-rank test.We assessed the factors that predicted motor and hrqol improvement with univariate regression analyses.Results: motor (41.6%; p=0.004) and hrqol (total score, p=0.039) improvements remained significant at long-term follow-up and, in the regression analysis, change in hrqol outcomes correlated significantly with change in motor outcomes (r2=0.384, p=0.010).Additionally, short-term motor and hrqol improvements predicted the long-term motor (r2=0.384, p=0.010) and hrqol (total score, r2=0.594, p < 0.001) outcomes, respectively.Conclusion: motor and hrqol improvements with dbs in isolated dystonia remain sustained for nearly a decade and may largely be predictable by the short-term response to dbs.Reported events: 5 patients with deep brain stimulation (dbs) for dystonia experienced subcutaneous infections that required removal of the device.Patient 12: an (b)(6) patient with bilateral gpi-dbs for dystonia had the leads replaced one year after the initial implantation because of migration, which the authors suspected may have been due to growth, as they were implanted when they were so young.Patient 13: a (b)(6) patient with bilateral gpi-dbs for dystonia did not show a good therapeutic response initially due to a suboptimally placed electrode on the left side, which was anterior to the postero-ventrolateral gpi.The authors suggested an additional surgery with a lead targeting the left postero-ventrolateral gpi and bilateral stn was performed, which led to 45% improvement in the long-term.The authors reported that patients were implanted with 3387 model leads and either activa pc/sc 37601-37603 or soletra 7426 neurostimulators.It was not possible to ascertain any additional 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: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 8744424
• MDR Text Key: 149637936
• Report Number: 3007566237-2019-01423
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2019

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?: Yes
• 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
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/28/2019
• 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): Required Intervention
• Patient Age: 37 YR