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

Model Number 37601

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Material Deformation (2976)

Patient Problem Electric Shock (2554)

Event Date 08/28/2014

Event Type  Injury  

Event Description

It was reported that a patient had a shocking sensation and an x-ray on (b)(6) 2014 indicated the twisting of wires.Etiology was possibly related to the device or therapy and possibly related to the implant procedure.The severity was mild.The extensions were replaced on (b)(6) 2015 and the event resolved without sequelae.

Manufacturer Narrative

Concomitant products: product id 37642, serial# (b)(4), product type programmer, patient; product id 3389s-40, lot# va0c8zq, implanted: (b)(6) 2014, product type lead; product id 3389s-40, lot# va0c8zq, implanted: (b)(6) 2014, product type lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type extension.(b)(4).

• 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: 4598554
• MDR Text Key: 5696086
• Report Number: 3004209178-2015-04679
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2015
• Date Device Manufactured: 11/26/2013
• 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: 00054 YR