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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7428
Event Type  Injury  
Event Description

It was reported the patient went to have an electrocardiogram (ecg) done in (b)(6) 2015 and prior to the ecg the cardiologist passed a magnet over the patient¿s pacemaker. The patient immediately began having seizure like movement called dystonic. The patient had drooping on one side of their face and the face was distorted, their speech was allured, and their right hand tightened and twisted, and their handwriting was affected on the right side. The slurred speech and the patient¿s face sagging lasted for about an hour. The patient was admitted to the hospital and they spent the night there for observation. Since the ecg, the patient had been tired and they were very anxious about having anything done to the pacemaker. The reporter stated the ¿seizure thing¿ was brief and stopped soon, the drooping in the face continued for a couple weeks, and the patient¿s hand writing gradually got better. In the past, the patient has had ecgs without interference. Since the patient last saw their healthcare professional (hcp) in 2010, they had not turned their devices off or made any adjustments to settings. Someone in the patient¿s assisted living center checks the devices with the patient programmer and last fall they could not get it to work so they stopped checking it. The patient was checked by their neurologist and they said the patient had dystonia. The hcp was not sure why this happened. The hcp thought the patient¿s implantable neurostimulators (ins) should be depleted by now, but the devices were tested and they were working, but low. The patient had not had a return of tremor so they did not see their hcp until now. The ins was on and working well. The ins battery was low at 2. 29v and the patient programmer did not show any lights indicating the battery was low. Impedances were measured to be normal. If the patient¿s tremor returned, they were going to schedule an appointment to have the ins replaced. The patient was about to have another ecg again and the nurse stated they could try turning the ins off and then back on. The nurse also mentioned using a pie plate to shield the magnet from the device. The patient did not have the symptoms of tremors before. The patient¿s hcp later reported the patient had a 50 percent or greater symptom reduction and they had recovered without permanent impairment.

 
Manufacturer Narrative

Concomitant products: product id: 7436, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# v239714, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v279715, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

 
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Brand NameKINETRA
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 Key4870903
Report Number3004209178-2015-12288
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 06/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/14/2010
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/08/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/27/2009
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: 06/26/2015 Patient Sequence Number: 1
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