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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INS 37604 ACTIVA PC+S NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO INS 37604 ACTIVA PC+S NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37604
Event Type  Injury  
Event Description

It was reported that ¿xxx¿ came up when the healthcare professional (hcp) ran therapy impedances three times. Voltage settings were changed, but that did not resolve the issue. No interleaving was being used and all electrode impedances were measured not be in normal range. The hcp was in the process of programming for therapy benefit and there was not anything that concerned them about the patient¿s therapy. The patient had four groups programmed the same using c+, 1- and they were using the second channel for recording. Stimulation was set at 2. 95v at the beginning of the programming session. One of the groups was programmed to 2. 8v and the other was at 3. 0v. The hcp met with the patient on the following day and a short circuit of 33 ohms was measured on electrode pair 0-2. The short had shown up intermittently in the past. Therapy impedances were measured to be 963 ohms. One port of the ins was being used for delivering stimulation and the other port had sensing lead-type of component that recorded activity and did not provide stimulation. Status of therapy was unclear. The hcp thought the patient was getting therapy from the left side ins, but may not be getting full benefit of therapy due to the right side programming issues. For the past six months, the hcp had been trying to optimize the patient¿s therapy due to the right side integrity issues due to impedances. A large different in impedances was noticed when impedances were run at 0. 7v and 3. 0v. The hcp was planning on replacing the extension on the right side. No outcome was reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Concomitant medical products: product id neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator; product id neu_unknown_lead, serial# unknown, product type: lead; product id neu_unknown_lead, serial# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator. (b)(4).

 
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Brand NameINS 37604 ACTIVA PC+S NEUROSTIMULATOR
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 Key4711516
Report Number3004209178-2015-07589
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/21/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2014
Device MODEL Number37604
Device Catalogue Number37604
Was Device Available For Evaluation? No
Date Manufacturer Received03/30/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/09/2013
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: 04/21/2015 Patient Sequence Number: 1
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