TEMPORARY PACING LEAD
Report
- Report Number
- 2182269-2023-00046
- Event Type
- Injury
- Date Received
- October 13, 2023
- Report Date
- November 13, 2023
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- LDF
- PMA / PMN Number
- K152784
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION REMAINS UNKNOWN.
THE FOLLOWING WAS PUBLISHED IN THE RADIOLOGY CASE REPORTS 18.10: 3615-3619. ELSEVIER INC. (OCT 2023) IN AN ARTICLE TITLED "CROSSED MY HEART, INTO THE GUT? A CASE OF CARDIAC PERFORATION WITH ACCOMPANYING DIAPHRAGMATIC PERFORATION DURING TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT", VARSHA RAKSHITHA PRAKASH; OP-016-1-AT (TRACK 9 -AT 2) THE PATIENT EXPERIENCED A PERFORATION REQUIRING SURGICAL INTERVENTION. THE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT OF AN URBAN TERTIARY HEALTH CARE INSTITUTE 4 HOURS AFTER AN EPISODE OF LOSS OF CONSCIOUSNESS, WHICH RESOLVED SPONTANEOUSLY, AND COMPLAINTS OF DIZZINESS AFTER THE EPISODE. THE PATIENT ALSO REPORTED FEELING DIZZY AND EXPERIENCING PALPITATIONS JUST BEFORE THE EPISODE. AFTER INITIAL MANAGEMENT, THE PATIENT WAS SHIFTED FOR TEMPORARY TRANSVENOUS PACING TO THE CATH-LAB WHERE FLUOROSCOPY-GUIDED VENOUS ACCESS TO THE RIGHT VENTRICLE WAS ATTEMPTED USING 6F CURVED, BALLOON-GUIDED BIPOLAR TEMPORARY PACING LEADS (PACEL, ABBOTT INC., MN) AS PER THE PROTOCOL BY THE CARDIOLOGIST ON CALL. WITH A FLUOROSCOPY-GUIDED APPROACH USING THE BALLOON-GUIDED CATHETER, LEADS WERE NAVIGATED VIA A TRANS-FEMORAL ROUTE INTO THE RIGHT ATRIUM AND THEN THE RIGHT VENTRICLE, WITH A SUDDEN GIVEAWAY IN RESISTANCE DURING FINAL VENTRICULAR POSITIONING. PACING RHYTHM WAS NOT ACHIEVED, AND PACING FAILURE WAS RECORDED, WITH THE LEADS IN PLACE, SUSPECTING A MYOCARDIAL PERFORATION. IMMEDIATE POINT-OF-CARE ECHO REVEALED NO MYOCARDIAL WALL MOTION ABNORMALITY, NO CHANGE IN THE EF, OR ANY PERICARDIAL EFFUSION, WITH ONE OF THE PACING LEADS SEEN GOING THROUGH THE RIGHT VENTRICLE. THE PATIENT REMAINED STABLE IN THE IMMEDIATE POST PROCEDURE PERIOD, AND WAS TAKEN FOR AN EMERGENT CT (COMPUTED TOMOGRAPHY) TO LOCATE THE POSITION OF THE PACING LEADS FOR ANY APPROPRIATE SURGICAL MANAGEMENT, IF NECESSARY. IMAGING REVEALED A LINEAR HYPER-DENSE STRUCTURE (PACING LEAD) TRAVELING VIA THE INFERIOR VENA CAVA INTO THE RIGHT VENTRICLE AND SEEN COURSING ALONG THE INFERIOR WALL OF RIGHT VENTRICLE OF THE HEART, CROSSING THROUGH IT AT THE APEX AND CROSSING THE UNDERLYING DIAPHRAGMATIC OUTLINE, INTO THE PERITONEAL CAVITY. A CARDIO-THORACIC AND VASCULAR SURGERY (CTVS) CONSULT WAS SOUGHT AND RECOMMENDED PERCUTANEOUS MANIPULATION AND TRANSVENOUS REMOVAL OF THE PERFORATING LEADS IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA AND FLUOROSCOPIC GUIDANCE IN THE EARLY POST-PROCEDURE PERIOD. THE PROCEDURE WAS CARRIED OUT SYNERGISTICALLY BY CARDIOLOGY, CRITICAL CARE, AND CTVS SERVICES, WITH NO COMPLICATIONS, WITH THE PATIENT REMAINING HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS THEN SHIFTED TO THE GENERAL WARDS FOR OBSERVATION AND FURTHER CONSERVATIVE MEDICAL MANAGEMENT BY THE CARDIOLOGY SERVICES. THE PATIENT REMAINED STABLE DURING CONSERVATIVE MANAGEMENT FOR A PERIOD OF 15 DAYS AND WAS ON CONTINUOUS CARDIAC MONITORING ACCOMPANIED BY REGULAR POINT-OF-CARE ECHO EXAMINATIONS THROUGHOUT THIS PERIOD. AFTER THAT, A PERMANENT PACEMAKER PLACEMENT WAS ACHIEVED ON THE 16TH DAY AND THE PATIENT WAS DISCHARGED FOR OUT-PATIENT FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1717411 | TEMPORARY PACING LEAD | ELECTRODE, PACEMAKER, TEMPORARY | LDF | ST. JUDE MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |