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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 06/07/2018

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 who was implanted with an implantable neurostimulator (ins) for parkinson's dual and movement disorders.It was reported that the patient's device suddenly turned off because the battery died and their tremors started the night prior to the report.It was reported that patient was currently in hospital and their ins depleted last night, and wanted to turn it back on.The caller currently had a charger going and charging the patient.The caller synced with the patient programmer and it showed the ins low battery, and the battery depletion issue was resolved.Caller was walked through the remote and the recharger, was charging the ins and it was too low to turn on yet.Caller stated that patient was at 1/4 or less.Caller was walked through how to turn on stimulation with recharger as well as the programmer.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient indicating that the battery was depleted because they forgot to charge it that week.Patient noted that they were able to turn device/stimulation back on after recharging the device, and the tremor was resolved.No further patient complications were reported/ anticipated as a result of this event.

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: 7591571
• MDR Text Key: 110753718
• Report Number: 3004209178-2018-13179
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• 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: 06/08/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 06/26/2018; 07/17/2018; 08/08/2018
• Supplement Dates FDA Received: 06/26/2018; 07/19/2018; 10/04/2018
• Date Device Manufactured: 08/30/2017
• 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 Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Weight: 109