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

Model Number 37603

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Swelling (2091); Complaint, Ill-Defined (2331); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

It was reported that a patient had an infection of the wound site.Around (b)(6) 2014, there were abnormalities in the rear wound site at the right auricular region, however no action was taken to address it.On (b)(6) 2014, there was swelling in the wound site at the right chest region.This was alleviated with treatment and medication.Treatment included administration of antibacterial drugs and hospitalization.Exacerbation sometimes occurred, but was handled in the same manner.There was only a bit of swelling as of (b)(6) 2014 at the patient¿s most recent consultation.The implantable neurostimulator (ins) was determined to have a causal relationship to the adverse event.The patient was concomitantly taking rivotril to treat dystonia.The patient had not recovered and died on (b)(6) 2014.It was determined that the death had no causal relationship with the device or therapy.

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 3389, serial# unknown, implanted: (b)(6) 2014, product type: lead.Product id: 37086, serial# unknown, implanted: (b)(6) 2014, product type: extension.(b)(4).

Event Description

Additional information reported the event was caused due to sequence of the events/symptoms rather than the individual event/symptoms.Other than the stimulator and lead the susceptibility was caused due to atopic dermatitis.

• 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: 4606189
• MDR Text Key: 5698197
• Report Number: 3004209178-2015-04783
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2015
• Date Device Manufactured: 01/10/2014
• 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): Hospitalization; Required Intervention