MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

Device Problems Failure to Deliver Energy (1211); Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant: product id neu_unknown_lead, product type lead.Product id neu_unknown_ext, product type extension.Product id neu_ptm_prog, product type programmer, patient.(b)(4).

Event Description

A consumer reported via a manufacturer representative that they had a revision on (b)(6) 2015, and they had experienced a loss of stimulation and therapy since then.This was characterized as a "sudden" change in therapy/symptoms.The consumer stated that the patient was told there would not be programming until september.It was noted that they were it doing well." troubleshooting/diagnostics and patient outcome were not reported.Follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.Indication for use: parkinsons dual.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 4962340
• MDR Text Key: 24654290
• Report Number: 3007566237-2015-02176
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• 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: 00067 YR