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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 37603
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# va0a6sn, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3389s-40, lot# va0ab21, implanted: (b)(6) 2013, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. (b)(4).

 
Manufacturer Narrative

(b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (s/n (b)(4) found no significant anomaly. The ins was functionally okay and there were insignificant anomalies.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was later reported the manufacturer representative spoke to the patient on (b)(6) 2014. The patient's implantable neurostimulator (ins) was changed out and the doctor decided that an ins replacement was a good place to start because it was least invasive. It was noted the doctor also had a theory that the ins was potentially malfunctioning and sending out extra stimulation when turned off. The patient recovered well and when the ins was turned on, 90% of the distal tremor was controlled, 100% of the resting tremor was controlled, and 85% of the proximal tremor was controlled. When the ins was turned off, there was still a small contraction, but it was only about 20% as strong as it had been with the previous ins. Two days later the patient was still getting good therapy, but the full force of the contraction when the stimulation was turned off was present again. One of the contractions that occurred after the ins was turned off was so strong some of the fillings came out of the patient's teeth. It was unclear whether this was due to biting down during contraction or due to another impetus. The patient was going to see their heath care provider on (b)(6) 2014 for another appointment.

 
Event Description

It was reported by the doctor that the patient may have a system malfunction as the left side of his body developed a tonic contraction that lasted 30 seconds when the right implantable neurostimulator (ins) was turned off. The patient was seen on (b)(6) 2014 by the doctor and manufacturer representative to have the system evaluated. The patient stated that he had minimal efficacy since (b)(6) 2013 and what little efficacy he did noticed had decreased recently. He was having more speech and tremor problems. Since that date the patient had noticed the tonic contraction on the left side of his face and neck at the moment the ins turned off. The contraction was intense for several seconds and he felt numbness in his tongue. The contraction faded away after ten to fifteen minutes. The configuration was changed multiple times and the contraction was less severe. The patient was not told when the ins was turned off in order to rule out the influence. It was discovered that if the settings were slowly decreased he felt increased parasthesias in his thumb and fingertips, but he did not have the face and arm tonic contraction. Impedances were taken in several positions and while palpating. The impedances were consistent throughout and within normal range. It was noted that the placement of the lead was ¿textbook¿ and there were no historical impedance values available. The patient had reprogramming once a month to address the efficacy issues. It was eventually decided that the patient would have his right ins and extension replaced on (b)(6) 2014. The surgery had not yet occurred, so the patient outcome was unavailable. Additional information will be requested after the reported surgical date and if additional information is received, a supplemental report will be sent.

 
Event Description

Additional information was received. It was reported the previous ins was defective and replacing it resolved the reported issues. No further complications were reported or are anticipated.

 
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
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
road 31, km. 24, hm 4
ceiba norte industrial park
minneapolis MN 55432
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263920
MDR Report Key4102298
Report Number3004209178-2014-17382
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 10/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/19/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/14/2014
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/06/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/16/2013
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: 09/19/2014 Patient Sequence Number: 1
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