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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number 3058
Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)
Patient Problems Therapeutic Response, Decreased (2271); Urinary Frequency (2275)
Event Date 01/01/2012
Event Type  Injury  
Manufacturer Narrative
Event date is approximate.Other applicable components are: product id 3889-28, lot# v237430, implanted: (b)(6) 2011, product type lead.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was implanted with a neurostimulator for urinary dysfunction/sacral nerve stim.It was reported that the patient¿s implant was replaced due to breaking their lead a few months before the replacement.The patient reported ¿some of them are left in there and are floating around¿.The patient also reported they were urinating more.It was noted that when the lead wasn¿t broken the implant worked for the patient.No further complications were reported.
 
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Brand Name
INTERSTIM II
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7075577
MDR Text Key93490603
Report Number3004209178-2017-24706
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00613994287724
UDI-Public00613994287724
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/01/2017
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? Yes
Device Operator Health Professional
Device Expiration Date07/28/2011
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/29/2017
Initial Date FDA Received12/01/2017
Date Device Manufactured02/12/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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