• 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 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 MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Event Type  Injury  
Event Description

It was reported that the patient only had an implantable neurostimulator (ins) implanted and the ¿cables¿ were no longer implanted due to infection. It was noted that ¿cables¿ were removed the year prior to this report due to bacterial infection. Patient needed an mri to assess for vertigo. Additional information requested but had not been received as of the date of this report.

 
Manufacturer Narrative

Concomitant products: product id 37085-40, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 37085-40, serial # (b)(4), implanted: (b)(6) 2011, product type extension; product id 3387s-40, lot # v550608, implanted: (b)(6) 2010, product type lead; product id 3387s-40, lot # v550608, implanted: (b)(6) 2010, product type lead. (b)(4).

 
Manufacturer Narrative

Concomitant medical products: product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 3387s-40, lot# v550608, implanted: (b)(6) 2010, product type: lead. Product id: 3387s-40, lot# v550608, implanted: (b)(6) 2010, product type: lead. (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 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
chad hedlund
7000 central avenue ne rcw215
minneapolis , MN 55432
7635149619
MDR Report Key3472688
Report Number3004209178-2013-20916
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/30/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/14/2012
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/05/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/14/2010
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: 11/15/2013 Patient Sequence Number: 1
-
-