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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  Injury  
Manufacturer Narrative

Product id 7426, serial# (b)(4), implanted: 2010 (b)(6); product type implantable neurostimulator product id 3387s-40, lot# v011138, implanted: 2006 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2006 (b)(6); product type extension product id 3387s-40, lot# v011138, implanted: 2006 (b)(6); product type lead product id 748251, serial# (b)(4), implanted: 2006 (b)(6); product type extension product id 7426, serial# (b)(4), implanted: 2010 (b)(6); product type implantable neurostimulator product id 7426, serial# (b)(4), implanted: 2010 (b)(6); product type implantable neurostimulator. (b)(4).

 
Manufacturer Narrative

Concomitant products: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator; product id 3387s-40, lot # v011138, implanted: (b)(4) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 3387s-40, lot # v011138, implanted: (b)(6) 2006, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2006, product type extension; product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator; product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator. (b)(4).

 
Event Description

Additional information received reported the patient was seen on (b)(6) 2014 due to freezing episodes. Patient had been doing well since placement in 2010 but over the past few weeks prior to the date of this report the patient had noticed that he had several episodes of freezing and falling secondarily. Patient also had deterioration of his general condition. The patient had problems with limb coordination. The patient was in a wheelchair, had cramping of the left hand, significant rigidity in all extremities and decreased coordination with alternating movements. It was noted that both implantable neurostimulators (ins) were interrogated and showed decreased voltages. It was noted that the impression was bilaterally failing inss. Replacement of the 2 devices was discussed and patient was going to proceed with surgery. Patient was having pain at a score of 8 in the right and left hand for the past 9 months prior to the visit on (b)(6) 2014. The patient had tingling and numbness. On (b)(6) 2014, it was noted that the device could not be turned off. The patient had an electrocardiogram scan. On (b)(6) 2014, patient¿s pre-operative status was parkinson¿s disease with bilateral failing devices. Post-operative was unchanged. Devices were replaced and impedances were adequate. The patient had returned to the recovery room without incident.

 
Event Description

It was reported, the patient was not able to use their hands. It was noted, the patient had pain, tingling, and numbness in their hands. It was stated, they had no mobility in their left hand and the left hand was worse than the right. It was noted, the condition had gotten progressively worse since (b)(6) 2013. It was stated they were unsure if the deep brain stimulator (dbs) still worked as it had been 4 years since their last battery change. It was noted they cortisone in their left hand at one time but it did not help. It was noted, the patient¿s condition ¿may not be due to the instrument itself. ¿ it was further reported, the patient had a loss of therapeutic effect. It was noted, the patient had fallen more than usual. It was stated in (b)(6) 2013, the patient had started to fall a lot but that was because they weren¿t taking one of their medications. It was stated when the patient got back on the medication their walking got better but in the last few weeks or months prior to report the patient¿s walking had gotten worse. It was noted, the patient had a magnetic resonance image (mri) performed on one of their arms a couple of months prior to report. It was further reported, the patient had a surgery the day prior to report to replace their batteries.

 
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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 Key3796324
Report Number3004209178-2014-08633
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/14/2011
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/27/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/23/2010
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: 05/07/2014 Patient Sequence Number: 1
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