FDA Adverse Event
Injury
Summary report: N
PENTA 3MM LEAD, 60 CM
MDR report key: 8923854
·
Received August 22, 2019
Report
- Report Number
- 1627487-2019-09640
- Event Type
- Injury
- Date Received
- August 22, 2019
- Date of Event
- August 6, 2019
- Report Date
- August 29, 2019
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT CODE SHOULD BE LGW RATHER THAN LSW AS PREVIOUSLY REPORTED.
Description of Event or Problem · 1
RELATED MANUFACTURER REFERENCE #:1627487-2019-09639. IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE SCS SYSTEM WAS REMOVED (DATE AND REASON UNKNOWN).
Description of Event or Problem · 1
RELATED MANUFACTURER REFERENCE #:1627487-2019-09639.
Description of Event or Problem · 1
RELATED MANUFACTURER REFERENCE #:1627487-2019-09639.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714683 | PENTA 3MM LEAD, 60 CM | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 4358173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |