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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 Unstable (1667)
Patient Problem Skin Erosion (2075)
Event Date 09/30/2021
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 provider regarding a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/ pelvic floor.It was reported that the device flipped in pocket and was eroding through skin.The device was removed on (b)(6) 2021 and a new device was placed on (b)(6) 2021.The pocket was moved to the other side.The issue was resolved.No further complications were reported.
 
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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 Key12606569
MDR Text Key276641607
Report Number3004209178-2021-15156
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00613994913654
UDI-Public00613994913654
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/11/2021
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? Yes
Device Operator Health Professional
Device Expiration Date09/14/2022
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/07/2021
Initial Date FDA Received10/11/2021
Date Device Manufactured03/24/2021
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 Age69 YR
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