MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC LEAD; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number MDT-LEAD

Device Problems Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574); Connection Problem (2900); Device Dislodged or Dislocated (2923); Impedance Problem (2950)

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Shock from Patient Lead(s) (3162)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.All information provided is included in this report.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.Patient information is limited due to confidentiality concerns.The gender of the baseline characteristics is male and the baseline age is approximately (b)(6).Without the specific model number(s), it is not possible to assure the specific product correction number referenced in the article is listed in this report.The date of death is not available at the time of this report, as there is no indication of specific serial number/patient information.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: aykan hh, karagoz t, gulgun m, et al.Midterm results of implantable cardioverter defibrillators in children and young adults from a single center in (b)(6).Pace pacing clin electrophysiol.2016;39(11):1225-1239.

Event Description

A journal article was reviewed which contained information regarding implantable cardioverter defibrillators (icds).Multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The article reported that there were patient deaths and patients who experienced inappropriate therapies, pocket infections, lead infections and acute bacterial endocarditis.The article reported that some patient received new systems.The article additionally reported complications throughout the study including lead connection problems, decreased defibrillation impedance, lead fracture and lead dislodgement.The status of the icds and leads is unknown.Further follow up did not yet yield any additional information.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC LEAD
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6211857
• MDR Text Key: 63468387
• Report Number: 2182208-2016-02935
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P900061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-LEAD
• Device Catalogue Number: MDT-LEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/01/2016
• Supplement Dates FDA Received: 09/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 12 YR