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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37701
Device Problem Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Incontinence (1928); Undesired Nerve Stimulation (1980); Pain (1994)
Event Date 01/01/2014
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 37702, serial#: (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator; product id: 3093-28, lot#: v162344, implanted: (b)(6) 2008, product type: lead; product id: 3093-28, lot#: v162344, implanted: (b)(6) 2008, product type: lead. Other relevant device(s) are: product id: 3093-28, serial/lot#: (b)(4), ubd: 07-oct-2012, udi#: (b)(4); product id: 3093-28, serial/lot#: (b)(4), ubd: 07-oct-2012, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient regarding their implantable neurostimulator (ins). Information was reported that the patient stated the device that was placed in 2014 ((b)(4)) did not help with fecal incontinence. The patient stated is also gave her pain in pelvic region. The patient went to her healthcare provider (hcp) multiple times for reprogramming with hcp staff and manufacturer representatives (reps). The patient stated the rep also called pats for assistance. The patient stated she would not feel stimulation in the correct area. The patient stated she had surgery three times to reposition the leads in 2014, 2015, and 2016. The patient was implanted with another ins, but stated she had it removed. The patient also noted having reconstructive surgery on her pudendal nerve. The patient stated the leads are placed correctly, but the sensation is not going to where it was supposed to be going. The patient stated the hcp retired and she is probably going to see a doctor. Additional information was reported that since the doctor performed procedures and used the leads in an off label manner the manufacturer representative (rep) was not able to provide technical assistance to either the patient or doctor during these cases. The reps were also not able to provide assistance with programming. No further information was reported.
 
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Brand NameRESTORE PRIME
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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 Key9981488
MDR Text Key196590179
Report Number3004209178-2020-07433
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2015
Device Model Number37701
Device Catalogue Number37701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/08/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/21/2020 Patient Sequence Number: 1
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