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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  
Event Description

It was reported that the patient was left in a nursing home, worse off. Prior to the patient getting the deep brain stimulator he could walk and talk but now he was confined to a hospital bed in a nursing home. The patient could barely feed himself. The patient had gone through the surgery wide awake ¿like a trooper. ¿ it had all gone downhill about 2 months after the deep brain stimulator surgery. The patient had good progress after the surgery for a week to a week and a half or two weeks. The patient was walking, talking, and doing exercises but after that the patient had become wheelchair bound and in a nursing home. The patient could not talk , walk or feed himself. The patient¿s system was checked two years prior to the date of this report. Patient¿s status was unknown. Reprogramming had been tried. The patient had been his healthcare professional¿s and still could not walk or talk.

 
Event Description

It was later reported the patient had deep brain stimulator surgery 4 years prior to the date of this report and it had worked great for almost 2 years but then things had gone downhill fast. The patient could not text.

 
Event Description

It was reported the patient got worse after surgery. The patient was diagnosed with parkinson¿s disease over the years prior to this report. The reporter stated the surgery did nothing for the patient. Additional information received reported that the patient had great results for two weeks. However, at the time of the report he was confined to a nursing home, where he could not walk, talk, or even make a phone call.

 
Manufacturer Narrative

 
Manufacturer Narrative

Concomitant products: product id: neu_unknown_lead, serial# (b)(4), product type: lead. Product id: 3387s-40, lot# v626366, implanted: (b)(6) 2011, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. (b)(4).

 
Manufacturer Narrative

(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 Key4762647
Report Number3004209178-2015-08838
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/14/2013
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/07/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/19/2012
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: 05/11/2015 Patient Sequence Number: 1
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