MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Malaise (2359)

Event Date 05/11/2018

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 with an implanted neurostimulator (ins) for parkinsons dual and movement disorders.The caller reported that the patient encountered an unknown error code on the patient programmer and the patient was not feeling well.The caller reported that this was first observed on (b)(6) 2018.The caller called back on (b)(6) 2018 reporting that they checked the patient's ins and the unknown error code was an elective replacement indicator (eri) message.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received from the healthcare provider (hcp) reported the cause of the patient suddenly not feeling well was the battery showing the call the doctor signal, but not having the phone number to call the hcp¿s office.An appointment was scheduled for the patient with a pending replacement.It was noted the patient¿s weight wasn¿t documented as they hadn¿t been set yet.No further complications were anticipated.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7522881
• MDR Text Key: 108561809
• Report Number: 3004209178-2018-11174
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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: 11/14/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/30/2018
• Date Device Manufactured: 05/15/2013
• 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: 77 YR