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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97713
Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problem Electric Shock (2554)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 97714, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2021, product type: implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. The reason for call was pt stated on (b)(6) 2021 he had both ins removed.  pt stated the cervical ins was shocking pt and the leads quit working on the left side about a year and a half ago. Pt stated that he would bend over and feel a shocking sensation - pt stated the rep "brent" was notified a year ago - asked unknown rep last name. Pt stated brent no longer works for medtronic. Pt stated he is working with dr (b)(6) to have the implants replaced and he wants to talk to medtronic field reps and the dm regarding the replacement - pt stated that he feels as a "returning medtronic customer" he deserves the "white glove" treatment and he wants to feel "warm and fuzzy" about going with medtronic for his pain stim implants. Pss is sending an fyi message to the field regarding pt request. Additional information was received from the rep reporting that on (b)(6) 2021 it was noted that electrode 1 and 4 were had on the thoracic unit. Bad electrodes for cervical were noted in references. The thoracic unit was adjusted for better left thigh coverage, and had the patient turn off adaptive stimulation on the cervical unit. Then on 2021-06-08 it was noted that both systems (cervical and thoracic) were being scheduled for removal, then mri, then implants. The patient¿s group f1 and 2 were programmed for their back and legs. Additional information was received from the manufacturer representative (rep) on 2021-09-28 reporting that the patient mentioned they experienced faulty equipment all throughout the years of having stimulators. Their scs inss were removed on (b)(6) 2021. A rep had met with the patient recently ((b)(6) 2021) and educated them on the newest rechargeable ins. The patient was moving forward with having this ins reimplanted.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12680216
MDR Text Key277874181
Report Number3004209178-2021-15738
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2015
Device Model Number97713
Device Catalogue Number97713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/03/2014
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: 10/22/2021 Patient Sequence Number: 1
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