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

Model Number 37612

Device Problems Low impedance (2285); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported the patient was having a revision because their healthcare professional (hcp) suspected that the electrode combination of 0 and 1 was shorted.Electrode impedances ran on the day of this report was 2766 ohms.Therapy impedance with 0 and 1 used was 2871 ohms.The manufacturing representative was not sure when the issue started or what the hcp saw to suspect there was a short.The patient had no shocking or jolting.The patient¿s wife thought the issue ¿comes and goes¿ and sounded intermittent.No symptoms or outcome were 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

Concomitant products: product id: 3389s-40, lot# va01pn5, implanted: (b)(6) 2012, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37651, serial# (b)(4), product type: recharger.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 3389s-40, lot# va01pn5, implanted: (b)(6) 2012, product type: lead.(b)(4).

Event Description

Additional information received reported the extension was replaced.The issue was resolved after the replacement and the patient was doing well.

• 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 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: 4503157
• MDR Text Key: 20756650
• Report Number: 3004209178-2015-02727
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• Date Device Manufactured: 08/04/2014
• 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): Required Intervention