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

Model Number 37601

Device Problem Low Battery (2584)

Patient Problems Dementia (1808); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that in august, the patient had a dementia incident and they had to go to the hospital where they went into parkinson¿s crisis.The reporter stated that they thought the patient was not taking their medication.The implantable neurostimulator (ins) was found to be dead and the patient had to be put on a ventilator.The ins was replaced due to reaching end of life (eol).A manufacturing representative thought the ins was at normal eol due to the patient¿s high settings, but they were not sure.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Product id 3387s-40, lot# v280392, implanted: 2009 (b)(6); product type lead product id 3387s-40, lot# v250513, implanted: 2009 (b)(6); product type lead product id 37085-60, serial# (b)(4), implanted: 2009 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2009 (b)(6); product type extension.(b)(4).

Event Description

Additional information received reported the patient had an unrelated medical issue a few weeks before the implantable neurostimulator (ins) battery depletion.The cause of the issue was unknown and the manufacturing representative did not know if the incident was due to battery depletion.The ins was programmed an continuous mode and had been explanted.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4269437
• MDR Text Key: 5226302
• Report Number: 3004209178-2014-22023
• 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,Company Representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2014
• Date Device Manufactured: 06/03/2011
• 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): Other; Required Intervention
• Patient Age: 00064 YR