• 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 37602
Event Type  Injury  
Event Description

It was reported that the patient¿s second implant had been implanted in the right side chest for the left side of the body in (b)(6) 2014 and it was not working. The patient had a lead replacement on (b)(6) 2014 because it had not stopped the tremors and the patient was unable to talk. The reason for the lead replacement was because they had thought the lead was initially placed incorrectly. The lead replacement had not made any difference to her symptoms. The healthcare professional was aware of the symptoms and the patient was scheduled to see him on friday following the date of this report. The patient was also going for some speech therapy on april 1st due to not being able to talk and talking on the phone was a chore. The patient¿s original implant that they had in 2011 had worked perfectly and she had never had any problems but the one from (b)(6) 2014 had not been good since day one. The patient had tremors since the 2nd system implant in (b)(6) 2014. The patient had never had a speech problem prior to the deep brain stimulator implant, they had turned it up to get her left side to stop shaking partially and that was when the speech problems had started; soon after the surgery in (b)(6) 2014. The manufacturing representative had tried to change it and he was unable too, nothing worked and this had been in march or april prior to the date of this report. It was noted that the manufacturing representative had no knowledge of any concerns. No outcome was provided. Further follow-up is being conducted. If additional information is received a supplemental report will be submitted.

 
Manufacturer Narrative

 
Manufacturer Narrative

Concomitant medical products: product id 748351, lot# nhu241291v, implanted: (b)(6) 2014, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387s-40, lot# va0f2fu, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead; product id 3387s-40, lot# va0l4l4, implanted: (b)(6) 2014, product type: lead. (b)(4).

 
Event Description

Additional information received reported the patient was still having concerns regarding their device or therapy, but they were working with their healthcare professional or a manufacturing representative. The patient had an appointment on (b)(6) 2015.

 
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
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key4636047
Report Number3004209178-2015-05489
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/14/2014
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/06/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/14/2013
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: 03/26/2015 Patient Sequence Number: 1
-
-