MEDTRONIC LEAD
Report
- Report Number
- 2182208-2022-00460
- Event Type
- Injury
- Date Received
- February 14, 2022
- Date of Event
- January 1, 2021
- Report Date
- February 14, 2022
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DXY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: POSITIONAL ATRIAL SENSE FAILURE IN A RATE-DROP PACEMAKER CAUSING FREQUENT TACHYCARDIA ATTACKS. WEST INDIAN MEDICAL JOURNAL. 2021; 69 (4): 261. DOI: 10.7727/WIMJ.2015.573. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: POSITIONAL ATRIAL SENSE FAILURE IN A RATE-DROP PACEMAKER CAUSING FREQUENT TACHYCARDIA ATTACKS. WEST INDIAN MEDICAL JOURNAL. 2021; 69 (4): 261. DOI: 10.7727/WIMJ.2015.573. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS POSITIONAL ATRIAL SENSE FAILURE IN A RATE-DROP IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE REPORTS A PATIENT WHO COMPLAINED OF TACHYCARDIA ATTACKS OF SHORT DURATION, PARTICULARLY WHEN THEY WERE ASLEEP WITHIN THE FIRST WEEK OF IMPLANT. A HOLTER TEST DEMONSTRATED THAT, WHILE THE PATIENT WAS ASLEEP, THE IPG FIRED TWO TIMES INAPPROPRIATELY. INTERROGATION OF THE DEVICE WITH TELEMETRY DID NOT DIAGNOSE ANY PROBLEM WITH ATRIAL AND VENTRICULAR SENSE, CAPTURE, OR IMPEDANCE PARAMETERS, BUT TELEMETRY HAD RECORDED FIVE RATE-DROP EPISODES IN ONE WEEK. REPROGRAMMING WAS PERFORMED, BUT THE PATIENT CONTINUED TO HAVE RECURRENT SHORT TACHYCARDIA ATTACKS WHEN THEY WERE ASLEEP EVEN THOUGH THE FREQUENCY OF TACHYCARDIA WAS DECREASED. IT WAS DISCOVERED THAT THERE WAS POSITIONAL ATRIAL UNDERSENSING DUE TO DISLODGMENT WHEN THEY WERE LYING SUPINE THAT CAUSED THE DEVICE TO INTERPRET IT AS ATRIAL ASYSTOLE AND TRIGGER A RATE-DROP RESPONSE. THE RIGHT ATRIAL (RA) LEAD WAS REPOSITIONED AND APPEARS TO BE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS POSITIONAL ATRIAL SENSE FAILURE IN A RATE-DROP IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE REPORTS A PATIENT WHO COMPLAINED OF TACHYCARDIA ATTACKS OF SHORT DURATION, PARTICULARLY WHEN THEY WERE ASLEEP WITHIN THE FIRST WEEK OF IMPLANT. A HOLTER TEST DEMONSTRATED THAT, WHILE THE PATIENT WAS ASLEEP, THE IPG FIRED TWO TIMES INAPPROPRIATELY. INTERROGATION OF THE DEVICE WITH TELEMETRY DID NOT DIAGNOSE ANY PROBLEM WITH ATRIAL AND VENTRICULAR SENSE, CAPTURE, OR IMPEDANCE PARAMETERS, BUT TELEMETRY HAD RECORDED FIVE RATE-DROP EPISODES IN ONE WEEK. REPROGRAMMING WAS PERFORMED, BUT THE PATIENT CONTINUED TO HAVE RECURRENT SHORT TACHYCARDIA ATTACKS WHEN THEY WERE ASLEEP EVEN THOUGH THE FREQUENCY OF TACHYCARDIA WAS DECREASED. IT WAS DISCOVERED THAT THERE WAS POSITIONAL ATRIAL UNDERSENSING DUE TO DISLODGMENT WHEN THEY WERE LYING SUPINE THAT CAUSED THE DEVICE TO INTERPRET IT AS ATRIAL ASYSTOLE AND TRIGGER A RATE-DROP RESPONSE. THE RIGHT ATRIAL (RA) LEAD WAS REPOSITIONED AND APPEARS TO BE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 884290 | MEDTRONIC LEAD | IMPLANTABLE PACEMAKER PULSE-GENERATOR | DXY | MEDTRONIC, INC. | MDT-LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Female | Hospitalization| R | UNKNOWN ICD |