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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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MPRI SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON Back to Search Results
Model Number 978A128
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/02/2021
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 provider via a manufacturer representative regarding a patient during post-op.It was reported that the chronic lead of the patient was displaced.  it was a non-workable lead because of displacement.  the physician removed the lead.  no further information was reported regarding the explant.
 
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Brand Name
SURESCAN
Common Device Name
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key12752400
Report Number2649622-2021-22008
Device Sequence Number6233402
Product Code EZW
UDI-Device Identifier00763000203603
UDI-Public00763000203603
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P970004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/04/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date12/10/2022
Device Model Number978A128
Device Catalogue Number978A128
Device Lot NumberVA2CE1K
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/02/2021
Initial Report FDA Received Date11/04/2021
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;
Patient Age78 YR
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