MICRA
Report
- Report Number
- 9612164-2016-01246
- Event Type
- Malfunction
- Date Received
- December 9, 2016
- Date of Event
- October 14, 2016
- Report Date
- October 14, 2016
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- PNJ
- PMA / PMN Number
- P150033
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN REPOSITIONED THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SEVEN TIMES DUE TO LOW SENSING VALUES AND HIGH THRESHOLDS. THE IPG WAS DEPLOYED THE EIGHT TIME AND VALUES WERE ACCEPTABLE. THE TETHER WAS CUT AND REMOVED. AFTER REMOVAL OF TETHER, ELECTRICAL TEST WAS PERFORMED AGAIN, THE R WAVE WAS DECREASED AND PACING THRESHOLD WAS HIGH. X-RAY IMAGES SHOWED NO SIGNIFICANT DISLODGEMENT OR DISPLACEMENT OF THE DEVICE. THE PHYSICIANS DECIDED TO RETRIEVE THE DEVICE BY SNARING. THERE WAS NO BLOOD CLOT OR TISSUES ON THE SURFACE OF THE RETRIEVED DEVICE. THE PATIENT WILL RECEIVE AN IPG IN THE FUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 807867 | MICRA | LEADLESS PACEMAKER | PNJ | MEDTRONIC IRELAND | MC1VR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |