• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37702
Device Problems High impedance (1291); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problem Electric Shock (2554)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that the patient feels stim is not working as it well as it has in the past and this has been a gradual change (unknown date). Patient runs stim high but still isn't getting relief. Caller noted that patient turns off at night because in certain positions they feel a strong "zap" (unknown when this started). Caller stated that patient has been reprogrammed couple times in the past (unknown dates) and now they aren't getting any relief. Caller provided group settings as follows: 1. 2v, 390 pw, 60 rate, greater than 4000 ohms, 16 hours/day; battery voltage is 3. 0v. Caller also mentioned that there are contacts over 10k ohms that aren't being used in programming. Technical services (tss) performed and reviewed longevity estimate of "greater than 10 years". The issue was not resolved through troubleshooting. The caller was redirected to tss reviewed that battery curve and eri trippoint and that likely high impedances have been conserving battery life.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRIMEADVANCED
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11832183
MDR Text Key250918711
Report Number3004209178-2021-07800
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2016
Device Model Number37702
Device Catalogue Number37702
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-