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U.S. Department of Health and Human Services

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

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7426
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v354660, implanted: (b)(6) 2009, product type: lead. Product id: 7438, serial# (b)(4), product type: programmer, patient. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

 
Event Description

It was reported that the patient was complaining of the device spontaneously turning off. The device was turned back on at the healthcare providers (hcp) office. Testing was completed including battery voltage and impedances and both were normal and within range. Reprogramming was also completed. Before the patient left the office, the device had turned off again. Then it was then turned on, as well before the patient left. When the patient was home, the device powered of again, and then the patient turned in back on with his hand held patient programmer. The patient status at the time of report was alive with no injury. It was later reported that the patient was having trouble with holding silverware to have breakfast the morning of the report due to his hand shaking. The patient noted that (b)(6) his hands were shaking more and then got relief in the right hand by adjustment. It was then reported that a battery was purchased for the patient programmer, the ins was off, and then the patient turned stimulation back on. The patient felt a shock in his arm, which was noted to be normal when the implant was turned back on. Then, the patient was getting control of his hand again and was receiving effective therapy.

 
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Brand NameSOLETRA
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 Key4078222
Report Number3004209178-2014-16734
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/18/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/10/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date04/14/2011
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/18/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/22/2009
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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