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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Erosion (1750)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Information was received from a healthcare professional (hcp) via manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had erosion of the right extension wire up and behind the ear.The cause was unknown.A replacement occurred on (b)(6) 2020 to replace the right extension.The issue was resolved at the time of report.No further complications were reported/anticipated.
 
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Brand Name
ACTIVA
Common Device Name
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key9859603
Report Number2649622-2020-05716
Device Sequence Number3332222
Product Code MHY
UDI-Device Identifier00643169449152
UDI-Public00643169449152
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P960009
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date09/16/2023
Device Model Number3708660
Device Catalogue Number3708660
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/16/2020
Initial Report FDA Received Date03/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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