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

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 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 PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Device Problem Device Operates Differently Than Expected
Event Date 06/12/2015
Event Type  Malfunction  
Event Description

It was reported the night prior to this report, the patient started feeling a vibration in their right arm at the inside of their elbow every ten seconds. The patient¿s pain level was a three on a scale of 1-10. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
Event Description

Additional information reported that the patient did not have concerns with their device or therapy now. The patient received assistance from their healthcare professional or manufacturer representative on 2015 (b)(6) and their concerns were resolved.

 
Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# va0gvdy, implanted:(b)(6) 2014, product type: lead. Product id: 3387s-40, lot# va0gvdy, implanted: (b)(6) 2014, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708695, serial# (b)(4), implanted:(b)(6) 2014, product type: extension. Product id: 3708695, serial# (b)(4), implanted:(b)(6) 2014, product type: extension. (b)(4).

 
Manufacturer Narrative

 
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information was received from the health care professional (hcp) that reported the patient experienced vibration and shock-like pain at the right inner elbow for 9-10 seconds for approximately 6 hours on (b)(6) 2015. It was noted this resolved. The patient also experienced shock-like pain and vibration at the left heel for 9-10 seconds for 90 minutes. Troubleshooting included reprogramming and device interrogation. The patient recovered without permanent impairment.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
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 Key4882932
Report Number3004209178-2015-12559
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,CONSUMER,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/12/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/14/2015
Device MODEL Number37601
Device Catalogue Number37601
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 Received08/14/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/24/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-