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

Model Number 37601

Device Problems Low impedance (2285); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported the patient programmer showed an out of regulation (oor) message.The patient wanted to know if the oor message meant the implantable neurostimulator (ins) was no longer functioning because their symptoms had worsened considerably in recent weeks.The patient later reported the ins stopped working and they had an appointment scheduled for a replacement on (b)(6) 2014.A short in the patient¿s system had been found so the whole system was replaced.Following the replacement, the patient was receiving effective therapy.

Manufacturer Narrative

Concomitant medical products: product id 37642, serial# unknown, product type: programmer, patient.(b)(4).

Event Description

Additional information received reported that one electrode read 47 ohms when impedances were checked.The patient did not have any falls or trauma.The cause of the short was not determined.The entire system was replaced and the patient was fine.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4394483
• MDR Text Key: 5124343
• Report Number: 3007566237-2015-00051
• 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: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2015
• 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 Outcome(s): Required Intervention