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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 INCON

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON Back to Search Results
Model Number 3058
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Erosion (2075); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Date of event: no information.If information is provided in the future, a supplemental report will be issued.
 
Event Description
(b)(6) 2021 (b)(4) (rep, hcp): information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient¿s pocket where the battery was located is infected.  the hcp indicated that the patient type was thin and may have attributed to the erosion of the skin and increased risk of infection.The device was explanted and antibiotics were prescribed due to the infection with a plan to replace the device once the patient heals.The issue was not resolved at the time of the report.
 
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Brand Name
INTERSTIM II
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13118604
MDR Text Key283083922
Report Number3004209178-2021-19153
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00763000449711
UDI-Public00763000449711
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/30/2021
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? No
Device Operator Health Professional
Device Expiration Date01/28/2023
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/23/2021
Initial Date FDA Received12/30/2021
Date Device Manufactured07/29/2021
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 SexFemale
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