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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 Problems Failure to Deliver Energy (1211); Defective Device (2588)
Patient Problems Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
Event Date 07/29/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event was reported as follows: loss of stimulation = 4-5 days ago ((b)(6) 2018); return of symptoms = in the last 4 days "or so" ((b)(6) 2018).Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient stopped feeling the stimulation 4-5 days ago and then started to have a loss of control/return of symptoms ¿because her bladder wasn't working good at night and it was bad¿.As an action taken prior to report, the patient had previously increased the stimulation to 5.1 volts but still did not feel it.Using the programmer, it was determined that the stimulation was on.During the report the patient increased to 8.5 volts on program 1 but still did not feel the stimulation.The patient was redirected to their healthcare professional (hcp) for the issue.There were no further complications reported or anticipated.
 
Manufacturer Narrative
Corrected information.If information is provided in the future, a supplemental report will be issued.
 
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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 Key7758335
MDR Text Key116905957
Report Number3004209178-2018-17590
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 Other
Type of Report Initial,Followup
Report Date 10/03/2018
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 Date09/14/2019
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/03/2018
Initial Date FDA Received08/07/2018
Supplement Dates Manufacturer Received08/08/2018
Supplement Dates FDA Received10/03/2018
Date Device Manufactured03/26/2018
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 Age66 YR
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