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

Model Number 3389S-40

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Nausea (1970); Visual Impairment (2138)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturing representative regarding a patient who was implanted with a neurostimulator (ins) for parkinson's dual and movement disorders.It was reported that the patient had a stage 1 lead placement.During intra-op testing, patient reported nausea and that he couldn't see very well.They moved the lead and the symptom resolved.Post-op, the patient was complaining still of his vision not being as good as it was prior to the procedure.Patient has history of surgery in both eyes and caller thinks she was told the patient had a displaced retina in one of his eyes as well.Patient did have an optic exam which patient responded to appropriately.They are planning on doing a stroke protocol to rule that out.Reviewed that the mri can be done when just the leads are in place.Leads were placed yesterday and capped.The patient also has a history of polio in the past and patient has progressed parkinson's disease.It was reported to be a sudden change in therapy/symptoms.No further complications were reported or anticipated with this event.Additional information was received from the manufacturing representative indicating that no mri was performed, no actions/interventions were taken, no cause was determined, and the issue is resolved.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7491979
• MDR Text Key: 107524882
• Report Number: 2649622-2018-07729
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169752276
• UDI-Public: 00643169752276
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2018

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 Expiration Date: 10/10/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1MYNU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/07/2018
• Date Device Manufactured: 12/27/2017
• 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): Other
• Patient Age: 69 YR