• 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 SOLETRA 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 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7426
Event Type  Injury  
Manufacturer Narrative

Concomitant product: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator. (b)(4).

 
Event Description

It was reported that around (b)(6) 2013, the patient¿s symptoms had gotten worse, they had tremor on their right side, and their limbs were distorted. After the implantable neurostimulator (ins) was implanted on the right side the patient¿s symptoms on their left side were controlled well. The patient was then implanted with an ins on their left side to control the symptoms on the patient¿s right side. On the same day the patient¿s healthcare professional adjusted the target position of the right ins. Following surgery the patient felt the left ins was heavier than the right ins, but the symptoms were controlled well. On (b)(6) 2014, the patient¿s limbs were trembling, their joints were distorted and their symptoms had gotten worse. The patient was reprogrammed on (b)(6) 2014, but their symptoms did not improve. Follow up with a manufacturing representative indicated that the cause of the event was not determined and it was unknown if intervention was done or if the patient was receiving effective therapy. No interventions or outcome were reported regarding this event. Additional information could not be obtained. Should additional information be received the event will be updated. Refer to manufacturer report #3004209178-2014-18342.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSOLETRA
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 Key4144132
Report Number3007566237-2014-02852
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/15/2014
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: 10/06/2014 Patient Sequence Number: 1
-
-