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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37603
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.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, 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 Key5004132
Report Number3004209178-2015-16041
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation Other
Type of Report Initial
Report Date 07/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/14/2012
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/14/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/14/2015 Patient Sequence Number: 1
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