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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 37602
Event Type  Death  
Event Description

Additional information received reported that the patient was in hospice care and dying prior to the event and had not been receiving any therapeutic benefit from the implantable neurostimulator (ins). It was also noted that the patient had fallen at some point and that the device was checked to determine if it was working in an effort to keep the patient as comfortable as possible in their last days. It was during the device check that it was determined that there was a "break" in the ins system. It was reported that the increase in the patient's symptoms was the result of the fall that caused a "break" in the device system. It was also reported that the device did not contribute to the patient's death (no cause of death was reported). The neurologist then recommended that it be turned off and that the patient be made comfortable with medications. It was believed that the device system remained in the patient. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension. Product id 748251, serial# (b)(4), product type: extension. Product id 3387-40, lot# j0313910v, implanted: (b)(6) 2003, product type: lead. Product id 3387-40, lot# j0313910v. (b)(4).

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported the device got an out of regulation (oor) message. Symptoms reported included that he could not move or swallow, was drooling, and had difficulty talking. The symptoms were present prior, but got worse 3 days prior to report. Three days later it was reported the patient was in hospice care and was not doing well. The patient had fallen. Upon interrogation of the device with a clinician programmer, a message read "delivered amplitude will be less than expected. " therapy measurement read "high. " three days later it was reported the patient passed away due to natural causes. It was reported that it was not related to the device that the reporter was aware of. Although death was attributed to natural causes, it is not clear if the device event, including loss of therapy, was related to the death.

 
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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 55431 554
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55431-5543
7635263987
MDR Report Key2806465
Report Number3004209178-2012-09618
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/29/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/26/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/14/2012
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received01/17/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/18/2011
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: 10/26/2012 Patient Sequence Number: 1
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