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

Model Number 37603

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

It was reported they were unable to adjust stimulation.They questioned whether the stimulation was on or not.The device was powered off.Troubleshooting occurred and using the on/off controls they were able to resolve the issue with checking to see if the patient¿s stimulation was on or off.The patient¿s stimulation was turned back on for therapeutic use.The symptoms had a sudden onset.The patient was at their health care professional¿s office 9 days prior to report for a programming adjustment and they checked their settings the day prior to report with their patient programmer.The patient had noticed a difference in stimulation on the morning of report.The patient had freezing of their left leg and foot.They had been having problems with the therapy for the last week.They had issues and so they were seen by the manufacturer representative in june and the patient went at the end of (b)(6) to get the settings changed and something ¿wasn¿t right¿ so they went back in the week prior to report for another programming adjustment.The last programming adjustment helped with their prior symptoms ¿for the most part.¿ the patient felt okay.The stimulation was noted to be back on.

Manufacturer Narrative

Concomitant medical products: product id 37642, serial# unknown, product type: programmer, patient; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3389s-40, lot# v846964, implanted: (b)(6) 2012, product type: lead.(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: 4073049
• MDR Text Key: 4856104
• Report Number: 3004209178-2014-16626
• 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: Other
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2014
• Date Device Manufactured: 09/14/2011
• 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: 00065 YR