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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  Injury  
Event Description

It was reported that there was a revision on the date of this report and the healthcare professional was seeing shorts. Just the batteries were involved in the revision; the patient had not wanted the extension revised at the time of this report. The first time there was a sign of the problem was 3-4 months prior to the surgery. The patient had turned the right battery off because of discomfort. The patient could not think of a specific incident or fall that may have damaged the system. The patient felt the programming made him uncomfortable. The impedance issue had first occurred preoperatively during impedance test, no stimulation difference had been felt by the patient. Impedance measurements before were c/0-3672, 0/2-4014 and 0/3-4517. The cause of the impedance issue was not determined. Both batteries were changed out and because therapy impedance was normal after battery change the patient¿s spouse had not wanted the extensions changed at that time to fix the open circuits that were not being sued in the patient¿s current program. The patient had never felt like the therapy had been great in the past several years since implant. Stimulation just kept getting higher and higher without increased benefit but with greater discomfort. Reference manufacturer¿s report number: 3004209178-2014-24139.

 
Manufacturer Narrative

Concomitant medical products: product id: 748240, serial# (b)(4), product type: extension. Product id: 3387-40, lot# s00185936, product type: lead. Product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 7482a40, serial# (b)(4), product type: extension. Product id: 3387-40, lot# j0118279v, product type: lead. (b)(4).

 
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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 Key4337253
Report Number3004209178-2014-24141
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/14/2014
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Date Manufacturer Received11/25/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/25/2012
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: 12/17/2014 Patient Sequence Number: 1
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