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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 3387S-40
Medical Device Problem Code Low impedance (2285)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/05/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that healthcare provider tested impedances, low impedances were discovered, and provider switched out for a different lead and impedances were all within normal range. cause is unknown.
 
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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 Key11808765
Report Number2649622-2021-09473
Device Sequence Number19703280
Product Code MHY
UDI-Device Identifier00643169752290
UDI-Public00643169752290
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
P960009
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/18/2021
Device Model Number3387S-40
Device Catalogue Number3387S-40
Device Lot NumberVA1UBXA
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/05/2021
Initial Report FDA Received Date05/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age69 YR
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