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

Model Number 37612

Device Problems Intermittent Continuity (1121); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

It was reported that the patient felt a surging sensation.When she used a transcutaneous electrical nerve stimulator (tens) unit on her back at the physical therapist's office a couple of weeks prior to the report, she felt her stimulation increase and had to turn stimulation down with her programmer.No intervention or patient outcome was reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant medical devices: product id: 3391s-40, lot# v525595, implanted: (b)(6) 2011, product type: lead, product id: 3391s-40, lot# v525595, implanted: (b)(6) 2011, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.

• 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: 4669480
• MDR Text Key: 16859443
• Report Number: 3004209178-2015-06190
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• 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: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2015
• Date Device Manufactured: 09/27/2012
• 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