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

Model Number 37603

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Dysphasia (2195); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Date 09/06/2011

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v750613, implanted: (b)(6) 2011, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.(b)(4).

Event Description

The consumer reported that her device was off at the time of the report as it was not helping her.The patient planned to go to her doctor the week after the report to get it looked at.Additional information from the consumer reported she had many concerns- side effects etc.As of (b)(6) 2011, her concerns were not resolved.The patient still had concerns regarding her device and therapy but she was working with her doctor/ manufacturer's representative.An appointment was set for (b)(6) 2012.The patient went in for her appointment and the device was interrogated by the hcp.The device was turned off on (b)(6) 2012 for mri.She had not been using the system due to poor tremor control.The patient was scheduled for surgery on (b)(6) 2012 for 2nd gpi lead replacement/ revision, a manufacturer's representative was to be present at the surgery.The first lead at the ventral intermediate nucleus (vim) was not enough to control tremor; the second vim lead was placed with the primary cell (pc), dual battery.The tremor was under control, the outcome was great.The patient never had therapeutic effect, she had tremors in her right hand and head, poor speech and her balance was off.There was speech decrease and poor lead placement.The first lead that was put in didn't work so well so the doctor put in another one.It was noted that the patient had 1 lead placed in the left side of the brain then the other lead was placed next to that lead because of lead placement.The patient had two leads in the same hemisphere/ target area for tremor control.The hcp initially went to insert a 2nd probe into the subthalamic nucleus but when they were doing the procedure; the hcp realized it was not having any effect on the tremors.They decided to reinsert another probe into the same nucleus at first.The 2nd probe was giving 70-80% relief from the tremors in her right hand.No further information was reported.If additional information is received, a follow up report will be sent.

• 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: 5004132
• MDR Text Key: 23013812
• Report Number: 3004209178-2015-16041
• 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,health professional
• Reporter Occupation: Other
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2012
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2015
• Date Device Manufactured: 04/14/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 00074 YR