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

Model Number 37602

Device Problems Battery Problem (2885); Communication or Transmission Problem (2896); Power Problem (3010)

Patient Problems Shaking/Tremors (2515); No Information (3190)

Event Date 04/01/2018

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 consumer regarding a patient with an implanted neurostimulator (ins).The patient reported that they were experiencing poor communication with the patient programmer and the patient programmer was not working.The patient reported that this started about a month ago.The patient reported that it had become more difficult to turn the ins on and off because of the poor comm.The patient reported trying new batteries in the patient programmer and tried unplugging the antenna and using the patient programmer directly but the issue remained.The patient reported that they could not tell whether their ins was on or off and the patient clarified that their hands would shake whether the implant was on or off.The patient did not recall seeing an elective replacement indicator (eri) or end of service (eos) message.No further patient complications have been reported as a result of this event.On (b)(6) 2018, crts 3716784, (con): omitted information regarding previous poor communication issue/pp antenna replacement.See pe (b)(4).Additional information was received from the patient reporting that they went to see their managing healthcare provider (hcp) who determined that their ins's were low and they will be replaced.The patient reported they found one at 2.59v and the other at 2.81v.The patient reported the replacement surgery was scheduled for (b)(6) 2018.No further patient complications have been reported as a result of this event.On (b)(6) 2018, patltr, (con): additional information received from the patient.The patient reported that they needed to replace their ins battery in order to resolve the poor coupling and other reported issues.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.

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: 7677793
• MDR Text Key: 113670468
• Report Number: 3004209178-2018-15487
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 03/17/2014
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 159