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

Model Number 37601

Device Problems Failure to Deliver Energy (1211); Unexpected Therapeutic Results (1631); Low Battery (2584); Device Operates Differently Than Expected (2913)

Patient Problem Shaking/Tremors (2515)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

The wife of the patient reported a loss of stimulation, and that the implant is not working since about two months after implant which occurred on (b)(6) 2014.It was stated that the implant is just sitting there doing nothing, and that the healthcare provider (hcp) confirmed it was not working with nothing they could do about it.However, the reason why it was not working could not be clarified, and it was noted that the patient is currently on hospice care for parkinson's.Additional information received from the wife of the patient on (b)(6) reiterated that they don't believe the implant has been working since the patient's last medical event.On (b)(4) the wife of the patient reported that the first implant done in 2010 always worked the best.It was stated that the last implant put in didn't last long because they had to have the energy set high to get any benefit, and they are pretty sure both batteries are used up now.The batteries are known to be gone because the patient has tremors on their hand.The patient has been on hospice care for over a year prior to date notified and have not had the implants checked, but have improved since then and are now off hospice care.Follow up will be conducted with the healthcare provider (hcp) on the thursday following date of additional information to check the implants.Indication for implant is movement disorders.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6016937
• MDR Text Key: 57098124
• Report Number: 3004209178-2016-21499
• Device Sequence Number: 1
• Product Code: MHY
• 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
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• Date Device Manufactured: 06/25/2014
• 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 Age: 85 YR