MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Headache (1880); Dizziness (2194); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

No information for date of event.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 movement disorders.It was reported that the patient was having unknown symptoms after touching an electric fence.Caller doesn't have any further info on the symptoms.Caller states impedances are within normal range.It was reported to be a sudden change in therapy/symptoms.No further complications were reported or anticipated with this event.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturing representative indicating that the patient did not report nor did the nurse any change in therapy or symptoms.They fell it's not related to the device or therapy.It is unknown when this event occurred.Symptoms included dizziness and headaches.Troubleshooting involved seeing the patient's nurse, who reported no impedance issues with her ins.Patient was sent to get an mri for the symptoms from shock on electric fence.Actions/interventions will be following up after the mri is done.They are still evaluating the patient, so it is unknown if the issue is resolved.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7540926
• MDR Text Key: 109361969
• Report Number: 3004209178-2018-11763
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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,Followup
• Report Date: 06/06/2018

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: 11/28/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 06/06/2018
• Date Device Manufactured: 06/02/2016
• 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