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

MAUDE Adverse Event Report: NEURO - VILLALBA 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
 

NEURO - VILLALBA ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 3389-28
Event Date 08/27/2014
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id 3389-28, lot# 0208153643, implanted: (b)(6) 2014, product type: lead; product id 37601, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 3389-28, lot# 0208153643, implanted: (b)(6) 2014, product type: lead; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 37085-60, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

 
Manufacturer Narrative

 
Event Description

It was reported that the lead implant procedure took place on (b)(6) 2014. On (b)(6) 2014 the patient developed a confusional state with apathy and mutism. No hemorrhage was detected on the head ct scan. The patient¿s hospitalization was prolonged. The reporter considered the event related to the leads. The reporter confirmed that the confusional state was due to local cerebral edema following the lead implantation, with effect of partial thalamotomy. No actions were taken. The event was resolved without sequelae on (b)(6) 2014. After implantation of implantable neurostimulator (ins) the patient experienced transient aggressiveness due to general anesthesia. The patient received atarax, one ampule. The event resolved without sequelae on the same day. Refer to manufacturer report number 6000153-2014-00191.

 
Event Description

Additional information received reported imaging was done and results were normal for patient. Etiology was surgery/anesthesia.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
NEURO - VILLALBA
call box 6001
villalba PR 00766
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 Key4241152
Report Number6000153-2014-00192
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative,COMPANY REPRESENT
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/10/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/14/2018
Device MODEL Number3389-28
Device Catalogue Number3389-28
Device LOT Number0208413215
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 Received04/07/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/14/2014
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: 11/10/2014 Patient Sequence Number: 1
-
-