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

Model Number 37602

Device Problems Break (1069); High impedance (1291); Unintended Collision (1429)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3389, lot#: unknown, product type: lead.Product id: 3389, serial/lot #: unknown.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Subthalamic nucleus deep brain stimulation in post-infarct dystonia.Kantharuby tambirajoo, luciano furlanetti, michael samuel, keyoumars ashkan.Doi: 10.1159/000509317 abstract: dystonia secondary to cerebral infarcts presents months to years after the initial insult, is usually unilateral and causes significant morbidity.Deep brain stimulation (dbs) of the globus pallidus internus (gpi) is established as the most frequent target in the management of the dystonic symptoms.We report our experience with subthalamic nucleus (stn)dbs in 3 patients with post-infarct dystonia, in whom gpi dbs was not confidently possible due to the presence of striatal infarcts.Two patients had unilateral stn dbs implantation, whereas the third patient had bilateral stn dbs implantation for bilateral dystonic symptoms.Prospectively collected preoperative and postoperative functional assessment data including imaging, medication and neuropsychology evaluations were analyzed with regard to symptom improvement.Median follow-up period was 38.3 months (range 26¿43 months).All patients had clinically valuable improvements in dystonic symptoms and pain control despite variable improvements in the burke-fahn-marsden dystonia rating scores.In our series, we have demonstrated that stn dbs could be an alternative in the management of post-infarct dystonia in patients with abnormal striatal anatomy which precludes gpi dbs.A multidisciplinary teambased approach is essential for patient selection and management.Reported events: it was reported that a patient hit their head on a metal bench 9 months after surgery and rapidly lost all stimulation benefit, reverting to their preoperative state.Interrogation of their system revealed high impedances, although ct and x-ray imaging didn't reveal any obviopus lead fractures.Despite attempts at multiple re-programming sessions the lost benefit wasn't regained.Subsequent surgical revision later revealed a lead fracture.Post-revision bipolar stimulation proved most efficacious resulting in improved ambulation and 60% improvement in foot and hand dystonia with minimal spasms.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: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10712159
• MDR Text Key: 216605158
• Report Number: 2182207-2020-01115
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• 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: 21 YR