FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 1031159
·
Received April 17, 2008
Report
- Report Number
- 1644487-2008-00946
- Event Type
- Injury
- Date Received
- April 17, 2008
- Date of Event
- April 1, 2008
- Report Date
- October 9, 2020
- Manufacturer
- LIVANOVA USA, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SERIOUS INJURY DID OCCUR, BUT DID NOT CAUSE OR CONTRIBUTE TO A PATIENT DEATH.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THE PATIENT WAS SCHEDULED FOR REVISION SURGERY. THE PATIENT HAD CHEST WALL PAIN THAT WAS CONSTANT. THE PAIN WAS BEING ATTRIBUTED TO THE POSITION OF THE LEAD AND GENERATOR. THEY HAD SURGERY TO REPOSITION THE GENERATOR AND LEADS. IT IS NOT KNOWN IF THE PAIN RESOLVED AFTER SURGERY.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S PAIN RESOLVED POST SURGICAL REPOSITIONING OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102R | LYJ | LIVANOVA USA, INC. | 102R | 016639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Hospitalization| R |