• 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  
Manufacturer Narrative

 
Manufacturer Narrative

Concomitant medical products: product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(4) 2008, product type: lead. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2008, product type: extension. Product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2008, product type: lead. (b)(4).

 
Event Description

It was reported that the physician¿s assistant (pa) called the reporter stating therapy impedance was high. The reporter did not have the settings or all of the impedance readings. The reporter stated that this may have been the first follow-up since implant and the patient was in for a suture check. The patient also complained of shocking down her jaw and leg that occurred every four to five minutes. The shocking would go away when the device was turned off. Palpation did not show anything and the ¿left was fine. ¿ the following day it was reported that the patient experienced shocking and a feeling of parasthesias in the left face, neck, tongue, cheek, and even in her leg that occurred every four to five minutes. It was also noted that during a clinician programmer programming session when the programmer head was pressed up against the implantable neurostimulator (ins) pocket she ¿felt a little something at the pocket. ¿ the patient was seen by the pa the day prior to the report and her impedances were checked. They looked to be within normal range, but it was noted that the clinician programmer indicated the therapy impedance was high. The reporter stopped by the clinic during the session and also got a high therapy impedance. They decreased the patient¿s voltage from 3 volts to 2. 8 volts and all of her shocking and parasthesias went away. The sensation that occurred when the programmer head touched the pocket site also went away. The patient had had good therapy since the most recent ins replacement and continued to get therapy after voltage was changed. They planned to keep an eye on the patient going forward for any changes. The patient was scheduled to be seen in (b)(6) 2014. Three days later it was reported that the patient still felt the shocking sensation, so the doctor was making arrangements to see her again the week of the report. Nine days later it was reported that the patient was to be seen again on (b)(6) 2014 for further investigation. The patient was tentatively scheduled for an extension revision. Additional information was requested, but was not available as of the date of this report.

 
Event Description

The additional information provided revealed that the issue was with the extension associated with the implantable neurostimulator (ins) in report #3004209178-2014-05906. All new information will be reported via that report.

 
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 Key3736838
Report Number3004209178-2014-05905
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/20/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/14/2014
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/10/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/19/2013
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: 04/09/2014 Patient Sequence Number: 1
-
-