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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 3708660
Device Problems Shipping Damage or Problem (1570); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the extension was found to be bent upon unpacking.The extension was replaced to complete the operation.The cause of the issue was unknown.No patient symptoms or further complications were reported as a result of this event.
 
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Brand Name
ACTIVA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8805458
MDR Text Key151574343
Report Number2649622-2019-12597
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 07/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/27/2022
Device Model Number3708660
Device Catalogue Number3708660
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2019
Date Device Manufactured11/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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