N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9391777
- MDR report key
- 9391777
- Report number
- 9614453-2019-03999
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-06
- Date received
- 2019-11-29
- 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 | ENSURA DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | MEDTRONIC EUROPE SARL | NVZ | EN1DR01 | EN1DR01 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-29 | 5076 | 1. H; 2. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT HIGH THRESHOLDS WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. AS A RESULT THE IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED PREMATURE BATTERY DEPLETION. THE LEAD AND IPG WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
N
Patient 1
PRODUCT EVENT SUMMARY:THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 86.4% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.