N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9828797
- MDR report key
- 9828797
- Report number
- 3008973940-2020-00618
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-09
- Date received
- 2020-03-13
- 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
- PAULA BIXBY
- Address
- 8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
- Phone
- 763-763-7635
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VITATRON A-SERIES IMPLANTABLE PACEMAKERS | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | MEDTRONIC SINGAPORE OPERATIONS | DXY | A20A1 | A20A1 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-13 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PACING LEADS WOULD NOT SCREW INTO THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS NOT USED AND REPLACED. THE LEADS WOULD ALSO NOT SCREW INTO THE REPLACEMENT IPG. THE IPG WAS REPLACED AND THE SECOND REPLACEMENT DEVICE WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.