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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 Date 04/18/2012
Event Type  Death  
Manufacturer Narrative

 
Event Description

Additional information received reported that the heath care professional (hcp) never had seen seizure symptoms with device. It was unknown if the symptoms were related to the device, therapy, or advancement of parkinsons disease as the seizure-like symptoms were observed in the er setting. Hcp did not know cause of seizure-like symptoms or cause of patient death. No intervention was reported.

 
Event Description

Additional information received reported that the patient saw a physician on (b)(6) 2012. At that time, both devices were dead (eol - end of life) and couldn't read them. It had been over a year since the devices were last checked, as the patient had not seen the physician for over one year. On (b)(6) the physician sent a referral to get the patient's batteries replaced, but not sure if this was ever done. At that time, the patient was in a nursing home and doing poorly. The patient's death had not been reported to the physician's office. If additional information is received, a supplemental report will be filed.

 
Event Description

It was reported that the patient was having seizure activity. The patient was going to the emergency room for a ct scan. They did not bring the programmer to the er. Additional reporting noted seizure-like symptoms. Ct scan came back within normal limits. The patient was "admitted" to er. There was no known accident or incident related to this issue. The patient had not been seen by managing health care professional since 2008. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

 
Event Description

Additional information was reported that the patient had died. The cause of death was advanced parkinson's disease. The patient had trouble swallowing and eating and it got progressively worse. The patient chose not to have a feeding tube. The patient had a urinary tract infection about a week before he passed. The caller was able to turn off one internal neurostimulator (ins) but not the other ins. In (b)(6), an ins was replaced. About a month before replacement the patient had difficulty swallowing and lost therapeutic effect. The caller did not know when the ins depleted. Device information could not be obtained. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Product id 748295 lot# (b)(4) implanted: 2005-(b)(6) explanted: product typ extension product id 748251 lot# (b)(4) implanted: 2005-(b)(6) explanted: product typ extension product id 7438 lot# (b)(4) implanted: 2005-(b)(6) explanted: product typ programmer, patient product id 3387-40 lot# v001105 serial# implanted: 2005-(b)(6) explanted: product typ lead product id 3387-40 lot# v001105 serial# implanted: 2005-(b)(6) explanted: product typ lead. Product id 7426 (b)(4) implanted 2009-(b)(6) explanted: product typ: neurostimulator. (b)(4).

 
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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 55431
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55431
7635263987
MDR Report Key2563223
Report Number3004209178-2012-03014
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 04/18/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date09/14/2010
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/23/2012
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/21/2009
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: 05/08/2012 Patient Sequence Number: 1
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