N
Patient 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
MAUDE MDR 9908492
- MDR report key
- 9908492
- Report number
- 2017865-2020-04500
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-19
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ELIZABETH BOLTZ
- Address
- 15900 VALLEY VIEW COURT SYLMAR CA 91342 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ZEPHYR XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | NVZ | 5826 | 5826 | P000086315 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
PATIENT FEMALE, (B)(6) OLD, (B)(6) KG. ABBOTT DUAL-CHAMBER PACEMAKER WAS IMPLANTED MORE THAN 10 YEARS AGO DUE TO THIRD-DEGREE ATRIOVENTRICULAR BLOCK. RECENTLY COMING TO THE HOSPITAL FOR TESTING, (B)(6) FOUND THAT THE PACEMAKER BATTERY WAS ABOUT TO RUN OUT, SO HE DECIDED TO REPLACE THE PACEMAKER. IT WAS REPLACED ON (B)(6), 2020. THE PACEMAKER MODEL WAS 5826 AND THE SERIAL NUMBER WAS (B)(4). THE PATIENT FOUND THAT THE PACEMAKER'S CURRENT CONSUMPTION WAS 41 MICROAMPERES WHEN THE PACEMAKER PROGRAMED THE PATIENT BEFORE DISCHARGE FROM THE HOSPITAL TODAY. THE REMAINING LIFE OF THE DEVICE IS SHOWN AS 1.75-2.75 YEARS. IN THE AFTERNOON, I PERSONALLY TRIED TO ADJUST THE PARAMETERS, BUT THE CURRENT CONSUMPTION OF THE PACEMAKER WAS STILL ABOUT 40 MICROAMPERES. (B)(6) WILL PERFORM 5826 REPLACEMENT SURGERY ON THE PATIENT LATER. THE PRODUCT WILL BE SENT TO THE COMPANY FOR FURTHER INSPECTION AFTER IT IS TAKEN OUT IN THE FUTURE.