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

Model Number 37602

Device Problems No Display/Image (1183); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

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 a neurostimulator (ins) for essential tremors, movement disorders.It was reported that their reason for calling was because when they go to turn their non-rechargeable dbs off for their left hand (controls their right brain) they were unable to turn it off.The patient reported that they first noticed the issue thursday night.The patient reported that when they tried to turn it off, they saw a picture of a telephone, a doctor, and oor.The patient confirmed they saw the oor on thursday night.The patient reported that the oor they were seeing could be related to the surgery they had last thursday.The surgery was unrelated to the device/therapy.It was reviewed how to bypass the oor screen.The patient confirmed they were successful with bypassing and saw on and ok and 3.00 a.The patient tried turning the stimulation off (patient noted that they turned the ins off every night when they went to bed), but reported that the oor screen had come back up.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received: it was reported that the patient was having a surgery and when they came home it would not turn off.Their doctor was able to get the device off and the issue was resolved.There were no further complications reported.

Manufacturer Narrative

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

Manufacturer Narrative

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: 7702996
• MDR Text Key: 114767673
• Report Number: 3004209178-2018-16164
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761064
• UDI-Public: 00613994761064
• 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,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• 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: 07/16/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 07/16/2018; 08/02/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/19/2018; 08/16/2018; 10/03/2018; 10/04/2018
• Date Device Manufactured: 10/24/2017
• 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: 65 YR
• Patient Weight: 70