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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 3389S-40
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
A manufacturer representative reported that the far-end size of the leads were only 1.0 mm but the standard was 1.5 mm in the product description.No symptoms were reported.There were no further complications reported/anticipated.Additional information received from the representative reported the lead was used in the surgery, there was no issue about safety, no actions or interventions were taken, and this was the only case.
 
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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 Key6429549
Report Number2649622-2017-02504
Device Sequence Number1103024
Product Code MHY
UDI-Device Identifier00643169313538
UDI-Public00643169313538
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P960009
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/23/2017
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 Date06/02/2019
Device Model Number3389S-40
Device Catalogue Number3389S-40
Device Lot NumberVA18YE4
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/06/2017
Initial Report FDA Received Date03/23/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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