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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 37612
Device Problems High impedance; Unintended Collision; Inappropriate Shock; Low impedance
Event Type  Injury  
Event Description

It was reported that the patient started complaining about right facial pulling and a shocking sensation in the chest region and cheek. It was noted that the patient fell last summer. The healthcare provider (hcp) met with the patient on (b)(6) 2015 and the combination of 2 and 3 was a short. The manufacturer representative (rep) then met with the patient on the day of the report and when they first ran impedances on the left implantable neurostimulator (ins) at 3 volts, all combinations with electrode 2 were high; greater than 7,000 ohms. The patient was programmed using case, 1, and 2. The rep had the patient do a left flexion and hold her head to the left and nothing was abnormal on the impedances. The rep had the patient lift her arm ¿life and pulled it back¿ while turning her face to the right side. This led to the patient¿s face on the right side starting to pull down and the shocking began as well in this position. The impedances were all within the normal range in this position and thus lower than the original measurements that were high. No lead fractures were noted and the cause was not determined. The patient was not receiving effective therapy and an extension revision was scheduled for (b)(6) 2015. After the revision the impedances were all within the normal range, except the combination of 2 and 3 which was 112 ohms. The patient was no longer experiencing a shocking sensation and was receiving effective therapy. The patient recovered without sequela.

 
Event Description

Additional information was received that indicated that x-rays showed leads appeared intact bilaterally. 2 skull views reveal neurostimulator leads present bilaterally overlying the deep brain. 2 cervical spine views revealed intact neurostimulator leads. There was loss of the normal cervical lordosis and endplate degenerative changes throughout the cervical spine with anterior osteophyte formation at c4-c5. There was disc narrowing at c5-c6 and c6-c7 along with moderate arthropathy and moderate uncovertebral joint degeneration. Lung apices were clear. Frontal and lateral views of the chest were done and findings indicated lungs were clear and there were no pleural effusions or pneumothorax. Cardio mediastinal silhouette was normal and bilateral stimulator leads overlie the mid lungs. Mild degenerative changes were seen in the spine.

 
Manufacturer Narrative

Concomitant medical products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 64001, lot# n356115, implanted: (b)(6) 2012, product type: adapter. Product id: 3387s-40, lot# v353787, implanted: (b)(6) 2009, product type: lead. Product id: 3387s-40, lot# v347165, implanted: (b)(6) 2009, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 37651, serial# (b)(4), product type: recharger. (b)(4). Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

 
Manufacturer Narrative

 
Manufacturer Narrative

Concomitant products: product id 37612, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 64001, lot # n356115, implanted: (b)(6) 2012, product type adapter; product id 3387s-40, lot # v353787, # implanted: (b)(6) 2009, product type lead; product id 3387s-40, lot # v347165, implanted: (b)(6) 2009, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2009, product type extension; product id 37651, serial # (b)(4), product type recharger; product id 7482a40, serial # (b)(4), implanted: (b)(6) 2009, product type extension. Analysis of the extension ((b)(4)) found a distal end weld non-conformance, coil-straight wire crimp sleeve. The #3 coiled wire separated from the transition crimp.

 
Manufacturer Narrative

Supplemental mdr submitted to add fdc to conclusion codes.

 
Manufacturer Narrative

 
Event Description

Additional information received reported it was confirmed with the doctor that x-rays were taken.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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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 Key4778467
Report Number3004209178-2015-09301
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/28/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2013
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Date Returned to Manufacturer05/14/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/03/2012
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: 05/18/2015 Patient Sequence Number: 1
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