MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INS 37604 ACTIVA PC+S NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37604

Device Problems Energy Output To Patient Tissue Incorrect (1209); Migration or Expulsion of Device (1395)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: neu_unknown_lead, lot# unknown, product type: lead.Product id: neu_ins_stimulator, lot# unknown, product type: implantable neurostimulator.Please note that the following device specifics were mentioned in the article: lead model 3389-40, resume ii lead model 3587a25, lead model 3391-40, extension model 3708740, activa pc+s implantable neurostimulator model 37604, and activa sc implantable neurostimulator.

Event Description

Swann, n.C., de hemptinne, c., miocinovic, s., qasim, s., ostrem, j.L., galifianakis, n.B., san luciano, m., wang, s.S., ziman, n., taylor, r., starr, p.A.Chronic multisite brain recordings from a totally implantable bidirectional neural interface: experience in five patients with parkinson's disease.Summary: here we describe our initial experience with a totally implantable first generation bidirectional neural interface that allows for both continuous therapeutic stimulation, and recordings of field potentials at multiple sites in a neural network: activa pc+s (medtronic).Reported events: unknown number of patients with dbs (with an additional cortical sensing lead) for parkinson's disease (pd) had minimal movement (less than 3.5mm) of the cortical electrode array, which was revealed by comparison of the intraoperative and postoperative ct (acquired between 3 weeks to 3 months after surgery).One patient with dbs (with an additional cortical sensing lead) for parkinson's disease (pd) had an episode of inadvertent activation of the cortical stimulation for 30-45 minutes, without clinical sequelae.[pli 30].

Manufacturer Narrative

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

• Brand Name: INS 37604 ACTIVA PC+S 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5621100
• MDR Text Key: 44134515
• Report Number: 3007566237-2016-01825
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37604
• Device Catalogue Number: 37604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• 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 Age: 56 YR