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

Model Number 37612

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dysphasia (2195); Shaking/Tremors (2515)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for parkinson¿s dual and movement disorders.It was reported the stimulator wasn't working too well.They were told by medtronic to change the settings.They were at 3.4 v on both sides.The patient was losing their voice and being shaky.The symptoms were off and on and were getting worse.The patient wanted to adjust the device.They were redirected to follow up with their hcp.It was clarified the ins was working and they felt better today.No further complications were reported as a result of this event.Pt says she spoke with the clinical specialist (b)(6) yesterday, he called somewhere else at mdt and they called her yesterday.Pt says her stimulator was not working too well.They told her yesterday to change the settings.She is at 3.4 v on both sides.Pt described she was loosing her voice and being shaky.Pt says symptoms were off and on and are getting worse.Pt called hcp office and they had a vm machine.Pt does not think her hcp knows of the above.Pt called to ask if there is any way she could adjust it.Redirected to hcp.Pss called pt back the next day to clarify about 'it was not working too well'.Pt says no, 'ins was working'.Pt still haven't talked to anyone about the above.Pt also states she feels better 'today' ((b)(6)).

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.Patient weight was updated.The circumstances leading to the issues was noted as level change to the programming.The patient wasn't sure if it has been resolved.Both the settings were on 3.4 right now.They think the right side should be higher but they weren't sure.They couldn't tell.No further complications were reported as a result of this event.

Manufacturer Narrative

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

• 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: 7491148
• MDR Text Key: 107752580
• Report Number: 3004209178-2018-10260
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2018

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: 02/28/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 06/01/2018; 06/01/2018
• Supplement Dates FDA Received: 06/01/2018; 06/01/2018
• Date Device Manufactured: 03/30/2017
• 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 Age: 69 YR
• Patient Weight: 57