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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Pain (1994); Inadequate Pain Relief (2388); Sleep Dysfunction (2517)
Event Type  Injury  
Manufacturer Narrative

Concomitant products: product id: 977a260, serial#: (b)(4), product type: lead. Product id: 977a260, serial#: (b)(4), product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 25-oct-2017, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 25-oct-2017, udi#: (b)(4). 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). It was reported that the leads were left implanted but the stimulator was removed. Pt stated the therapy worked okay at first but had to be set really high so the charge didn't last long. Pt stated they met with a mdt rep who adjusted the therapy a bunch of times but could never get great relief. Patient stated it didn't work. Pt stated they had the stimulator removed and a year or two later they discovered the leads were still implanted when they had a chest x-ray at a physical. Pt stated the lead was "wavy" and 4-5 mins from the spine so they think that may be why the therapy didn't really work. Pt mentioned no falls/trauma. Pt stated they have a fused vertebrae and sleeping was painful. Pt mentioned they reported this removal to the previous agent (prs)that they spoke with before patient services. Pt mentioned the ins was removed but the leads remain implanted.

 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12043268
MDR Text Key257494818
Report Number3004209178-2021-09765
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 06/22/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/14/2014
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/17/2013
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: 06/22/2021 Patient Sequence Number: 1
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