• 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. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

  • 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. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97702
Device Problems High impedance (1291); Low impedance (2285); Impedance Problem (2950)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
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 (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that incidental finding of out of range impedances on one lead.No factors were known to contribute to the event.Patient receiving good stimulation.Group used is on the other lead. incidental finding while checking battery voltage on primary cell device.No actions taken and the impedances were not resolved.No symptoms were reported.Additional information was received from the rep and it was reported that the patient had low impedance.
 
Event Description
Additional information was received from the manufacturer representative (rep).Electrode impedances showed that lead 8-15 are all out of range.Impedance test showed that 8-15 are all high.Rep programmed patient using only the 0-7 lead.Stimulation was fine.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SURESCAN
Type of Device
STIMULATOR, 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
MDR Report Key11773312
MDR Text Key251480226
Report Number3004209178-2021-07184
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169109513
UDI-Public00643169109513
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/03/2021
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 Date01/28/2018
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/28/2021
Initial Date FDA Received05/04/2021
Supplement Dates Manufacturer Received06/02/2021
Supplement Dates FDA Received06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age76 YR
Patient Weight64
-
-