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 9908677
- MDR report key
- 9908677
- Report number
- 2938836-2020-02375
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-26
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- 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 | ASSURITY MRI | IMPLANTABLE PACEMAKER PULSE GENERATOR | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | LWP | PM2272 | PM2272 | A000076048 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-02373; 2938836-2020-02374. IT WAS REPORTED THAT DURING IN CLINIC CHECK, LOW IMPEDANCE WAS OBSERVED ON THE RIGHT ATRIAL AND VENTRICULAR LEADS. THE PHYSICIAN ALSO ALLEGED MALFUNCTION ON THE PACEMAKER. THE NOISE WAS NOT REPRODUCIBLE BUT CURRENTLY, THE CLINIC STILL RECEIVED IMPEDANCE ALERTS ON MERLIN.NET. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED SINCE HE WAS NOT PACEMAKER DEPENDENT.