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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number 3058
Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id 3889-28, lot# va03zyt, implanted: (b)(6) 2012, product type lead.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care professional regarding a patient who was implanted with an implantable neuro stimulator (ins) for gastrointestinal/pelvic floor it was reported that patient device was off due to broken wires.It was also reported that patient was experiencing major bowel and gi issues.No further complications were noted or anticipated.
 
Manufacturer Narrative
Device code (b)(4) pertains to the lead.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp).The hcp reported that the ins was removed for an unknown reason and that a partial ghost lead was left in the patient.No further complications were reported or were expected.
 
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Brand Name
INTERSTIM II
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key7084993
MDR Text Key94732301
Report Number3004209178-2017-24904
Device Sequence Number1
Product Code EZW
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/07/2018
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 Date01/14/2014
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/04/2017
Initial Date FDA Received12/05/2017
Supplement Dates Manufacturer Received01/30/2018
Supplement Dates FDA Received02/07/2018
Date Device Manufactured07/20/2012
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;
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