MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Break (1069); Migration or Expulsion of Device (1395); Malposition of Device (2616); Charging Problem (2892); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems Hemorrhage/Bleeding (1888); Pocket Erosion (2013); Heart Failure (2206); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

Helmers a-k, lübbing i, birkenfeld f, witt k, synowitz m, mehdorn hm, falk d, complications of impulse generator exchange surgery for deep brain stimulation: a single-centre, retrospective study, world neurosurgery (2018), doi: 10.1016/j.Wneu.2018.01.183.Age/date of birth: this value is the average age of the patients reported in the article as this specific patient could not be identified.Sex: this value reflects the sex of the majority of patients reported in the article as this specific patient could not be identified.Date of event: please note that this date is based off of the accepted date as the event dates and publication date were not provided in the published literature.Concomitant medical products: product id neu_ins_stimulator lot# unknown serial# implanted: explanted: product type implantable neurostimulator.Product id neu_unknown_ext lot# unknown serial# implanted: explanted: product type extension.The main component of the system.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown, ubd: , udi#: asku.Product id: neu_unknown_ext, serial/lot #: unknown, ubd: , udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Summary: non-rechargeable deep brain stimulation (dbs) impulse generators (ig) with a low or empty battery status require surgical ig exchange several years after initial implantation.Complication rates in patients undergoing dbs surgery range from 7.6% to 25.3%.The aim of this study was to investigate the complication rates after ig exchange surgery and to identify risk factors for complications.Complications following ig exchange surgery from 2008 to 2015 in a single-center university hospital setting were retrospectively analyzed.The medical records of all the patients who underwent ig exchange surgery were systematically reviewed.The shortest follow-up time was 19 months.From 2008 to 2015, 438 generators were exchanged in 319 patients.The overall complication rate was 8.90%.Twelve patients (2.74%) developed an infection related to the ig and underwent secondary removal of the ig, and two of these patients died from life-threatening dbs withdrawal syndrome, both of whom had parkinson¿s disease.Six patients (1.37%) suffered from local wound erosions surrounding the ig.For this particular complication, local wound revision was sufficient in all the patients.Hardware malfunctions occurred in 11 patients (2.51%), and local hemorrhage surrounding the ig and requiring surgical revision was observed in three cases (0.68%).Repeated fixation of the ig was required in two patients (0.46%).Traction of the connecting cables necessitated surgical revision due to patient discomfort in two patients (0.46%).The ig was placed abdominally or was exchanged for a smaller device due to patient discomfort resulting from the initial position in two cases (0.46%).One (b)(6) patient (0.23%) suffered from severely worsening heart failure and died four days after ig exchange surgery performed under local anesthesia.The infection rate was 1.79% after the first exchange, 3.23% after the second exchange and 8.57% after three or more exchanges.Ig exchange surgery, although often considered a minor surgery, is associated with a complication rate of approximately 9% in this center.Infection is the most relevant complication, as it may require removal of the ig.Implantation of smaller igs may reduce complications such as wound erosion or local hemorrhage.Patients and physicians should understand the complication rates associated with ig exchange surgery because this information may encourage selection of a rechargeable ig.Reported events: there were six cases of local wound erosion.It was noted that these minor complications led to delayed healing, extended hospital stays and additional surgery.In cases with exposed parts of the inss, local wound revision was done under antibiotics in the absence of infection.There were three cases of post-operative hemorrhage.Due to this, local wound revision was performed on the day of surgery or one day later without long-term consequences with respect to patient outcomes.It was noted that these minor complications led to delayed healing and extended hospital stay.Two patients without any signs of infection underwent local wound revision because of discomfort related to a migrating ins which needed to be re-fixed.It was noted that these minor complications led to delayed healing and extended hospital stay.Two patients without any signs of infection underwent local wound revision because of discomfort which required a second surgery due to traction or distortion of the cables.It was noted that these minor complications led to delayed healing and extended hospital stay.One patient without any signs of infection underwent local wound revision because of discomfort.The location of the ins was changed.It was noted that these minor complications led to delayed healing and extended hospital stay.One patient without any signs of infection underwent local wound revision because of discomfort.The ins was exchanged for a smaller, rechargeable device.It was noted that these minor complications led to delayed healing and extended hospital stay.There were five reported cases of malfunction of the contacts due to surgical error.All cases required surgical revision, but did not result in permanent worsening of the patient outcome.It was noted that these minor complications led to delayed healing and extended hospital stay.There were two cases of cable malfunction in which the cause was unclear.Surgical revision was required, but did not result in permanent worsening of the patient outcome.Exchanging the cables resolved the issue.It was noted that these minor complications led to delayed healing and extended hospital stay.There were two reported cases with unclear malfunctions leading to loss of function, which were unresolved.Both cases required surgical revision, but did not result in permanent worsening of the patient outcome.It was noted that these minor complications led to delayed healing and extended hospital stay.One patient experienced cable malfunction due to non-recognized damage of the cable during surgery.It was noted this was probably from a scalpel.Surgical revision was required, but did not result in permanent worsening of the patient's outcome.Exchanging the cables resolved the issue.It was noted that these minor complications led to delayed healing and extended hospital stay.One patient was unable to recharge the ins due to excessively deep placement of the ins when it was switched from a non-rechargeable device to a rechargeable device.Surgical revision was required, but did not result in permanent worsening of the patient's outcome.It was noted that these minor complications led to delayed healing and extended hospital stay.The therapy each patient was implanted for could not be identified; however, the article noted patients in this study were implanted for parkinson's disease, essential tremor, dystonia, or tremors caused by multiple sclerosis.The following device specifics were provided: ins models 7428, 7426, 37601, 37612, 37602, 37603.

• Brand Name: ACTIVA
• 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: 7504754
• MDR Text Key: 107962865
• Report Number: 3007566237-2018-01416
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2018

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: 37612
• Device Catalogue Number: 37612
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/10/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR