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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091); Complaint, Ill-Defined (2331); Impaired Healing (2378)
Event Date 03/16/2019
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 consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported by the patient that they got the device implanted and the next day when they woke up it was extremely swollen and bulging out.The patient stated that it ¿got red¿ and hurt a lot.The patient stated that it was not like the other two surgeries so they knew that something was wrong.The patient called their health care physician (hcp) office and talked to the nurse practitioner and that it was month before they did anything.The patient stated that they didn¿t do a culture but the hcp told the patient that it was a staph infection.The patient stated that they removed the whole system in (b)(6) 2019 and that they were on both oral and iv antibiotics.The patient stated that two months later after the system was removed they still couldn¿t close the wound because it was so infected.The patient chose to not get the device replaced.The hcp told them that they would have to get it on the other side and the patient stated that they would rather deal with their symptoms than go through what they went through with the infection again.The patient¿s reason for calling was to inquire what to do with their external devices and if the manufacturer company disposed of the old programmer? the patient was advised that the manufacturer company did not take them and that they should speak to their hcp or their city for how to dispose of them.There were no further complications reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer.The patient reported that the infection was resolved at this time.In response to the inquiry of the current status of the device, the patient stated they didn¿t know and noted that the doctor who removed it had left the practice.There were no further complications reported.
 
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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 Key9633559
MDR Text Key187590713
Report Number3004209178-2020-01910
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/19/2020
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 Date07/14/2020
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/14/2020
Initial Date FDA Received01/27/2020
Supplement Dates Manufacturer Received02/13/2020
Supplement Dates FDA Received02/19/2020
Date Device Manufactured01/24/2019
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 Age41 YR
Patient Weight84
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