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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  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v526048, implanted: (b)(6) 2010, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2011, product type: extension. (b)(4).

 
Event Description

It was reported that a patient was hospitalized for 6 months because her lungs/diaphragm stopped working. One was frozen and the other wasn¿t moving at all. After the patient had the deep brain stimulator (dbs) put in, she started having trouble swallowing, her voice changed, and she was choking all the time. While the patient was in the intensive care unit (icu) her dbs batteries went out. A couple of weeks after the battery went out, her throat started getting better- everyone said ¿you sound wonderful¿. The patient wondered ¿if the dbs affected her throat, could it also have affected her diaphragm¿. The patient was breathing out of the top 1-2 inches of her lungs. After about 3 minutes of standing, the patient would be gasping for air. She is on oxygen ¿24/7¿. The patient had organizing pneumonia and within 2 weeks it was ¿so acute¿. A biopsy was attempted, but it was unknown what the patient had, how she got it, or how to fix it and they haven¿t been able to help her at all. The patient¿s tremors were ¿so bad now¿. When the patient¿s dbs devices were put in, they were affecting her thoughts and she was having trouble saying the right words. When the patient would want to say (b)(6) it would come out (b)(6). When her thoughts would come out, they weren¿t organized. Since the batteries went dead, she can think and say the right words. No interventions or outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. A follow-up report will be submitted when more information becomes available.

 
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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 Key4096816
Report Number3004209178-2014-17214
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 08/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/28/2012
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received08/25/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/29/2010
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: 09/17/2014 Patient Sequence Number: 1
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