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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); Disconnection (1171); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2014
Event Type  malfunction  
Manufacturer Narrative
Information references the main component of the system and the other applicable components are: product id: 3889-28, lot# v998463, implanted: (b)(6) 2012, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer (con) and a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that the patient's wires got broken and were disconnected two years prior to the report.It was clarified that the device was not removed, but was shut off because of the broken wires.They were going into a new doctor on (b)(6) 2017 to see about having the device removed to have some mris.On (b)(6) 2017, the rep reported that they were not aware of the patient's wires being broken and they didn't have any further information on the issue.There were no symptoms or further complications reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that an explanted was scheduled for (b)(6) 2017 because the patient needed an mri.No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Explant date valid for ins and lead.Analysis of the lead (lot # v998463) found that all of the stimulation body conductors were broken at or near the tines, 5.1 cm from the distal end.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 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 Key7067325
MDR Text Key93709491
Report Number3004209178-2017-24515
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 company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2013
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/21/2017
Initial Date FDA Received11/29/2017
Supplement Dates Manufacturer Received11/28/2017
12/06/2017
02/20/2018
02/21/2018
Supplement Dates FDA Received11/30/2017
12/20/2017
02/21/2018
03/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2012
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 Age58 YR
Patient Weight64
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