N
Patient 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
MAUDE MDR 9901625
- MDR report key
- 9901625
- Report number
- 2124215-2020-03854
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-02
- Date received
- 2020-03-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- TIMOTHY DEGROOT
- Address
- 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US
- Phone
- 651-651-6515
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE EL DR | IMPLANTABLE DEVICE | BOSTON SCIENTIFIC CORPORATION | LWP | L321 | L321 | 701314 | * | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-30 | 0 | 1. H; 2. L; 3. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED DUE TO UNKNOWN REASONS. A REASONABLE EVIDENCE SUGGEST A POSSIBLE MALFUNCTION DUE TO THE SHORT IMPLANT PERIOD. A SURGICAL INTERVENTION WAS NECESSARY TO RESOLVE THE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.