• 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 KINETRA 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 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7428
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient was implanted on (b)(6) 2010 due to parkinson¿s disease. It was noted that after the operation the symptom was well controlled. The patient fell in (b)(6) 2013 and then had difficulty walking gradually. Patient was reprogrammed on (b)(6) 2013 and after the programming the symptom improved. One month later the patient appeared to have difficulty walking, swallowing and could not care for himself. Patient was now taking pills. Patient was told the ¿product could remain to use although the product used faster. ¿ additional information received reported the effect of programming was good but one month later the symptom existed. It was unobtainable as to whether any malfunctions were see or cause of issues determined. It was unobtainable whether interventions were taken or planned. Patient walking difficulty was aggravated, had difficulty swallowing, constipation and could not take care of himself.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameKINETRA
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 Key3519346
Report Number3004209178-2013-23553
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/27/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received11/27/2013
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: 12/13/2013 Patient Sequence Number: 1
-
-