FDA Adverse Event
Injury
Summary report: N
KIT IMPLANTABLE SLIM TIP LEAD, 90CM
MDR report key: 15481875
·
Received September 25, 2022
Report
- Report Number
- 1627487-2022-05072
- Event Type
- Injury
- Date Received
- September 25, 2022
- Date of Event
- August 11, 2022
- Report Date
- September 25, 2022
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027160
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7113351. COMMON DEVICE NAME: DRG SLIM TIP LEAD, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7113351.
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT EXPERIENCE INEFFECTIVE THERAPY. AS A RESULT, THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2535143 | KIT IMPLANTABLE SLIM TIP LEAD, 90CM | DRG SLIM TIP LEAD | PMP | ABBOTT MEDICAL | MN10450-90A | 7113351 | 05415067027160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | DRG IPG| DRG SLIM TIP LEADS |