• 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

It was reported that a day after the patient¿s device was implanted, she used an electromagnetic therapy device close to her chest for wound treatment for 4 days. Two day¿s after she started using the device, she experienced a burning sensation in her abdomen. Approximately a month later, the patient had a tingling sensation in her arm, which got worse about a week later. Reprogramming was performed several times but the cause of the event was unknown. The patient was hospitalized for treatment. As of (b)(6) 2014, the patient still experienced tingling sensations and felt weak. It was unknown if the patient was receiving effective therapy. If additional information becomes available, a supplemental report will be submitted.

 
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 Key4553593
Report Number3007566237-2015-00478
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Date Manufacturer Received02/01/2015
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: 02/27/2015 Patient Sequence Number: 1
-
-