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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number NEU_INTERSTIM_INS
Device Problems Break (1069); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
Patient Problems Injury (2348); Electric Shock (2554)
Event Date 01/01/2013
Event Type  malfunction  
Manufacturer Narrative
Other applicable components are: product id: neu_unknown_lead, lot#: unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient with an implantable neurostimulator (ins).The patient reported another patient stated that in 2013 the icon and device failed them, they were experiencing shocking and a broken lead wire that sent shocking to all the wrong places and caused personal injury.No other patient information or event details were provided.No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
INTERSTIM
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave ne
minneapolis MN 55421 1200
MDR Report Key9368221
MDR Text Key174162198
Report Number3007566237-2019-02409
Device Sequence Number1
Product Code EZW
Combination Product (y/n)N
PMA/PMN Number
P970004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 11/25/2019
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
Device Operator Health Professional
Device Model NumberNEU_INTERSTIM_INS
Device Catalogue NumberNEU_INTERSTIM_INS
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/22/2019
Initial Date FDA Received11/25/2019
Supplement Dates Manufacturer Received11/22/2019
Supplement Dates FDA Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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