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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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Event Type  Malfunction  
Event Description

It was reported the patient had a shocking or jolting sensation when they turned their head a certain way or sometimes when they turned their head left. The patient felt a shock like sensation in their chest and arm area that only occurred when the implantable neurostimulator (ins) was on. The patient¿s grandson had stepped on the ins at some point and the patient thought the issue started soon after. The patient had thought they had neck issues that created the sensation. When the patient met with their healthcare professional (hcp), they were more convinced the issue was related to their ins. Impedances had been checked and some electrodes were out of range. The following high impedances were measured on the right side at 3v: c-8 = 2521, c-9 = 2293, 8-9 = 4381, 8-11 = 4647 and 9-11 = 4194 ohms. The ins was turned off for three hours and the patient did not feel the sensation. X-rays were normal and everything else read normal. The patient had no obvious loss of benefit, but they were not doing as well as they once were. The patient was under a tremendous amount of stress and they had stopped exercising. The patient did have a reduction in symptoms control, but they also had a urinary tract infection that had caused some decline in the past. The cause of the event had not been determined and the patient had not recovered. The symptoms/issue were ongoing and the hcp was trying to figure out the problem. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Concomitant products: product id 3389s-40, lot # va0apc0, implanted: (b)(6) 2013, product type lead; product id 3389s-40, lot # va0apc0, implanted: (b)(6) 2013, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension; product id 3708660, serial # (b)(4), implanted: (b)(6) 2013, product type extension. (b)(4).

 
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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 Key4801009
Report Number3004209178-2015-09802
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/06/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2014
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/06/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/12/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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