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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 37601
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Additional information received reported that the patient was having the battery change out on the day of the report due to normal battery depletion. The patient had not had the implantable neurostimulator (ins) turned on for the past six months due to side effects. Since having the ins off, the patient continued to experience decreased muscle tone and vision, so he was scheduled for a mri. The physician did not think the symptoms were device related, but did not know what was causing them. It was noted that the right side ins impedances were slightly higher than normal. Combination case and 4, 4 and 6, and 4 and 7 were showing 3,900 to 4,300 ohms. The previous impedances on these combinations on (b)(6) 2014 were 6,600, 7,876, and 7,406 ohms respectively. On (b)(6) 2014 the impedances were 3,923, 3,574, and mid-4,000 to 5,000 ohms respectively. The ins was not going to be turned on after replacement as the patient was going to see the neurologist for programming. Four days later it was reported that everything went well after troubleshooting. The patient was doing fine.

 
Manufacturer Narrative

Concomitant products: product id 748266, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7428, serial # (b)(4), implanted: (b)(6) 2007, product type implantable neurostimulator; product id 7436, serial # (b)(4), product type programmer, patient; product id 748266, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 3389s-40, lot # v023165, implanted: (b)(6) 2007, product type lead; product id 3389s-40, lot # v024801, implanted: (b)(6) 2007, product type lead; product id 64002, lot # n268789, implanted: (b)(6) 2011, product type adapter; product id 3389s-40, lot # v063950, implanted: (b)(6) 2007, product type lead; product id 3389s-40, lot # v061739, implanted: (b)(6) 2007, product type lead; product id 7482a66, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 7482a66, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37642, serial # (b)(4), product type programmer, patient. (b)(4).

 
Event Description

It was reported on (b)(6) 2014 that there were some out of range impedances on the right side. The measurement of unipolar 4 was 6,600 ohms, 5 was 2,400, and 6 was 2,100. The impedances were not tested at a higher setting. The patient needed a mri for possible neurological issues. The patient was seen in september or october by his healthcare provider (hcp) and at the time he was getting great therapeutic benefit. Three to five days later the patient started to have vision lapses, which lasted a few seconds, and occurred every few hours. The patient also started to experience a loss of muscle tone in his legs after visiting the hcp, describing it as ¿giving out. ¿ this occurred a few times a day. The patient was seen by other physicians and they ruled out seizures. In december the patient¿s implantable neurostimulator (ins) was turned off completely and remained off at the time of the report. The patient still had some vision differences and his legs still gave out, but he was not falling as often. The reporter noted that the patient would be having a battery replacement due to it being near end of life (eol) from normal depletion. Five days later it was reported that the patient was doing fine and he was scheduled for a battery replacement ¿in a few weeks. ¿ the following day it was reported that there were out of range impedances on the left side. However, it was noted that typical numbering suggested the impedances were for the right side. Thus, it was unclear which side had out of range impedances.

 
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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 Key3830756
Report Number3004209178-2014-09587
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date09/14/2012
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/23/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/14/2011
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: 05/23/2014 Patient Sequence Number: 1
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