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

Model Number 37601

Device Problems Electromagnetic Interference (1194); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Date 08/08/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# va0ng8z, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va0vgkw, implanted: (b)(6) 2015, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.(b)(4).

Event Description

A consumer reported the patient did some welding and since then the deep brain stimulation (dbs) did not seem to be working as well.The patient's walking seemed to be more shuffling again.The patient's indication for use is parkinson's disease and movement disorders.No interventions 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.

Event Description

Additional information received from a consumer reported that the issue was resolved.

• 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: 5035157
• MDR Text Key: 26187982
• Report Number: 3004209178-2015-16829
• 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: Patient Family Member or Friend
• Report Date: 08/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Date Device Manufactured: 05/01/2015
• 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: 00066 YR