Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MPRI INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number 3889-28
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 05/15/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Information was received from a consumer (con) via a manufacturer representative (rep) regarding a patient undergoing a stage 1 evaluation.It was reported that, after the stage 1 lead implant, the patient complained of leg pain.The patient was instructed to turn stimulation down and to never increase stimulation to a level of discomfort.The patient followed up with their doctor and was instructed to leave the device off for 4 days to see if the leg pain resolved, and to take aleve medication.On 2017-06-19, it was reported by a rep that the lead was removed.No further complications were reported/anticipated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTERSTIM
Common Device Name
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key6669578
Report Number2649622-2017-07590
Device Sequence Number16536794
Product Code EZW
UDI-Device Identifier00643169651111
UDI-Public00643169651111
Combination Product (Y/N)N
PMA/510(K) Number
P970004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/27/2017
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 Date04/26/2021
Device Model Number3889-28
Device Catalogue Number3889-28
Device Lot NumberVA1GGPT
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/19/2017
Supplement Date Received by Manufacturer06/19/2017
Initial Report FDA Received Date06/27/2017
Supplement Report FDA Received Date10/05/2017
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;
-
-