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

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA 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 NEUROMODULATION ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37612
Event Type  Injury  
Event Description

The patient was implanted on (b)(6) 2013 due to parkinson. After implantation, the patient felt the effect was not good. The physician reprogrammed the device many times, but the patient was still not satisfied with the effect. It was unknown if there was a 50% or greater symptom reduction. The patient was epileptic two times in the week after the surgery. The urine tube and gastric tube was not pulled out after the surgery. After surgery it was difficult for the patient to walk. Reprogramming results showed the device was normal. The patient was disequilibrium and dysphasia. No troubleshooting has been done and the event cause was not determined. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Concomitant medical products: product id: 3389s, product type: lead. Product id: 37085, product type: extension. Product id: 37651, product type: recharger. Product id: 37642, product type: programmer, patient. (b)(4).

 
Manufacturer Narrative

(b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACTIVA
Type of DeviceSTIMULATOR, 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 Key4824533
Report Number3007566237-2015-01573
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/19/2015
Was Device Evaluated By Manufacturer? No Answer Provided
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: 06/08/2015 Patient Sequence Number: 1
-
-