MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37601

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Neurological Deficit/Dysfunction (1982); Neck Pain (2433)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3389-40, lot# 0208002645, implanted: (b)(6) 2014, product type: lead.Product id: 3389-40, lot# 0207784005, implanted: (b)(6) 2014, product type: lead.

Event Description

A healthcare professional from a clinical study reported during normal use on (b)(6) 2015 the patient had worsening cervical dystonia and cervical pain.Diagnostics included examination and device interrogation which was normal for the subject.Actions taken included reprogramming and increase dosage of rivotril medication.No surgical intervention was required and it was unknown if any was planned.The event was related to programming/stimulation.The outcome was ongoing.Patient¿s medical history included hypertension, dyslipidemia, hyperlipidemia, non-statin oral medications, type ii diabetes, oral medications, diet, thyroid disorder, depression, dystonia and the patient was currently taking movement disorder and/or psychiatric medications.Additional information received reported a diagnostic examination was performed to identify the pain and cervical dystonia on (b)(6) 2016.Additional information received september 6, 2016 reported that the patient had an examination (b)(6) 2016 that identified cervical dystonia.Additional information was received from a health care provider (hcp) of a clinical study.It was reported that the diagnostic methods included an examination on (b)(6) 2016 that resulted in the identification of the issue.Imaging was performed on (b)(6) 2016 and resulted in suspicion that the leads migrated; the results are pending.No further complications were reported/anticipated.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a health care provider (hcp) of a clinical study.It was reported that the actions/interventions taken to resolve the event included repositioning the electrodes in a bilateral thalamic position; no post-traumatic lesion was visualized.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider (hcp).It was reported that the last reprogramming session the patient underwent was in (b)(6) 2017.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a health care provider (hcp).The patient was reprogrammed on (b)(6) 2018.The cervical dystonia is still present.No further complications anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a health care provider (hcp).It was reported that the patient was reprogrammed on (b)(6) 2019 and cervical dystonia was still present with blepharospasm.The patient had dysport injections.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6417323
• MDR Text Key: 70359881
• Report Number: 9614453-2017-00915
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2020
• Date Device Manufactured: 11/18/2013
• 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: 57 YR
• Patient Weight: 82