• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7428
Event Date 11/18/2014
Event Type  Injury  
Event Description

It was reported the patient was hospitalized on (b)(6) 2014 for walking difficulty. By (b)(6) 2014, the patient¿s symptoms of walking difficulty and leg weakness had not improved after taking medicine every day. The patient suspected the implantable neurostimulator (ins) was turned off accidently before they took their medicine. On (b)(6) 2014, the patient was reprogrammed and the ins was not turned off. The patient¿s healthcare professional did increase the voltage by 0. 1v and their symptoms got much better. The cause of event was not determined and the patient was doing well at the time of this report.

 
Manufacturer Narrative

(b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameKINETRA
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 Key4331580
Report Number3004209178-2014-23984
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/24/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date04/14/2014
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Date Manufacturer Received11/24/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/18/2012
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: 12/16/2014 Patient Sequence Number: 1
-
-