• 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

Analysis of the neurostimulator, serial #(b)(4), found no anomaly. It was connected to a known good extension and lead and the impedances were measured to be good on every electrode pair. It also functioned properly through other tests.

 
Event Description

Additional information reported there was a greater than 50% symptom reduction for the patient. The ins was confirmed to be involved with the event. Impedances were checked pre- and post-operation in july. The cause was not determined and it is unknown if it is device-related. The patient recovered without permanent impairment.

 
Manufacturer Narrative

Product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# v157349, implanted: 2008 (b)(6); product type lead product id 7482a66, serial# (b)(4), implanted: 2008 (b)(6); product type extension (b)(4).

 
Manufacturer Narrative

Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

 
Event Description

It was reported a few days following the patient¿s replacement surgery, they noticed a tingling on their chest as well as up and down their right arm. It was noted, the lead was in the left ventral intermediate nucleus (vim). The patient¿s right hand and arm would kind of go into a ¿flailing mode¿ and it would affect their motor coordination. It was described as intermittent shocking symptoms. The old implantable neurostimulator (ins) was at the exact settings but at a lower amplitude. An electrode impedance test was performed and c0 showed high at 2360 ohms. It was noted the intermittent shocking occurred a few times a day and they could reproduce it if the patient pushed on the ins. When the patient pressed on the ins the impedance test was redone and c0 showed 1217 and the tingling sensation faded. It was noted the issue appeared with 0. It was further reported on the day of report in the operating room they tried to re-enact the impedances but it showed normal the entire time. It was noted the doctor went ahead and replaced the ins on the day of report.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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 Key3922599
Report Number3004209178-2014-12719
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 06/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/28/2015
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/18/2014
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/13/2013
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: 07/09/2014 Patient Sequence Number: 1
-
-