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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
Event Type  Injury  
Event Description

It was reported the patient had been having trouble with their left hand getting shocked for a week. The patient had seen their healthcare professional (hcp) and they had run tests on the implantable neurostimulator (ins), but they were unable to give them any relief. The hcp had contacted another hcp that stated this type of shocking usually indicated a fault in one of the leads in the brain. The patient stated they were facing surgery probably in the next two weeks, but they were not sure when it would be. The patient stated the right lead was 15 years old so maybe it was worn out. The patient was trying to get an appointment with the mayo clinic at the time of this report. 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

(b)(4).

 
Event Description

Additional information received reported the patient still had concerns regarding their device or therapy, but they were working with their healthcare professional or a manufacturing representative. The patient had an appointment on 2014-(b)(6).

 
Manufacturer Narrative

 
Manufacturer Narrative

Concomitant medical products: product id 3389-40, lot# l73653, implanted: (b)(6) 1999, product type: lead; product id 37612, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3389-40, lot# l73653, implanted: (b)(6) 1999, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2002, product type: extension; product id 7482a40, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 3387s-40, lot# v046959, implanted: (b)(6) 2007, product type: lead; product id neu_ptm_prog, serial# unknown, product type: programmer, patient. (b)(4).

 
Manufacturer Narrative

 
Event Description

Additional information received reported the patient was doing better. The patient had a long reprogramming appointment and they were getting tremor control greater than 75 percent. No surgery was scheduled at the time of this report and the plan was to continue to program around the problem. The patient was told that a future surgery may be necessary if they can no longer program around the issue.

 
Event Description

Additional information received reported that an x-ray and ct scan showed no signs of lead disconnection or breaks. An impedance check showed a disconnect at contact five. The healthcare professional (hcp) stated lead zero and one were null.

 
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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 Key4399488
Report Number3004209178-2015-00372
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 12/19/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/28/2010
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/06/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/02/2009
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: 01/08/2015 Patient Sequence Number: 1
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