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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
Device Problems Low impedance; Battery Problem
Event Type  Injury  
Event Description

Additional information received reported the patient was scheduled for the replacement of the lead, extension, and implantable neurostimulator (ins) on 2015-(b)(6). The patient had a short on one contact, but even with reprogramming around the contact, the ins was rapidly depleting. The manufacturing representative did not know when the depletion started. The ins had not reached end of service (eos), but the ins was low. The patient had been programmed in continuous mode.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the manufacturer representative (rep) believed that there was a short in the system that was contributing to the implantable neurostimulator (ins) depleting too quickly. The patient was in a procedure at the time of the report and wanted to use an alligator clip to test the extension. There was no confirmation if a short was found or what the patient outcome was, so additional information was requested. If additional information is received a supplemental report will be sent.

 
Manufacturer Narrative

Concomitant products: product id: 3387-40, lot# j0225368v, implanted: (b)(6) 2002, product type: lead. Product id: 7438, serial# (b)(4), product type: programmer, patient. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, : product type: extension. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator. Product id: 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2002, product type: extension. (b)(4).

 
Manufacturer Narrative

 
Event Description

Additional information received reported that the lead, extension, and implantable neurostimulator (ins) were all re-implanted on the right side. Everything was functioning normal at the time of the report.

 
Manufacturer Narrative

 
Event Description

Additional information received from the patient via a manufacturer representative (rep) reported that there was an impedance failure on two of the leads on the right side implantable neurostimulator (ins) in (b)(6) 2014 with battery depletion. The plan was to do re-implantation of the right system on (b)(6)-2015; instead only an exploratory surgery was done and the right ins was removed. The post-op period was very challenging for the patient: there was an increase in medications, significant left leg tremors, and loss of function due to no ins. The patient had experienced component failure. The right system was completely replaced on (b)(6)-2015. The patient's outcome had been very good since with significant drug reduction and functional improvement. The patient's left side ins was replaced on (b)(6)-2015. Everything was working properly afterwards.

 
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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 Key4669659
Report Number3004209178-2015-06199
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE,CON
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2014
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/30/2012
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: 04/08/2015 Patient Sequence Number: 1
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