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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number 3058
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Abscess (1690); Bacterial Infection (1735); Erythema (1840); Skin Erosion (2075); Urinary Tract Infection (2120); Discomfort (2330)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient in a clinical study with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor issues.It was reported that the patient was prescribed antibiotics by their pcp approximately two weeks ago for a uti and the patient thought the device had moved; there was discomfort at the generator site about 3 weeks ago and their skin had eroded over the distal aspect of the generator, with some erythema but no purulence or discharge, and the area was tender.The clinical diagnosis was a gluteal abscess.It was noted that the event resulted in an unscheduled clinic or office visit and was related to the device or therapy and not related to the implant procedure.Diagnostics performed included laboratory testing which found aerobic bacteria, and an examination.Interventions taken included explanted and replacing the entire system, administering keflex 500mg tid x10 days, and wound care treatment.The outcome of the event was noted to be ongoing.No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported the patient¿s history of utis prior and since implant of the implantable neurostimulator (ins) was unknown; however, it was noted that the reported uti was related to the patient¿s underlying urinary dysfunction and the cause was unknown, but it was not related to the device/therapy.No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp).It was reported that the event was resolved without sequelae as of (b)(6) 2018.No further complications were reported/anticipated.
 
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Brand Name
INTERSTIM II
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
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 Key8086202
MDR Text Key127676730
Report Number3004209178-2018-25745
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00613994913654
UDI-Public00613994913654
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 health professional,study
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/07/2019
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 Expiration Date02/14/2016
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2018
Initial Date FDA Received11/19/2018
Supplement Dates Manufacturer Received01/02/2019
01/22/2019
Supplement Dates FDA Received01/15/2019
02/07/2019
Date Device Manufactured08/18/2014
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) Other; Required Intervention;
Patient Age84 YR
Patient Weight98
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