FDA Adverse Event
Injury
Summary report: N
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
MDR report key: 16903487
·
Received May 10, 2023
Report
- Report Number
- 1627487-2023-02146
- Event Type
- Injury
- Date Received
- May 10, 2023
- Date of Event
- April 13, 2023
- Report Date
- June 15, 2023
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027153
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT IS ESTIMATED.
Additional Manufacturer Narrative · 0
ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL:MN10450-50A, UDI:(B)(4), SERIAL:(B)(6), BATCH:6151565.
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-02144. IT WAS REPORTED THAT DUE TO HIGH IMPEDANCES ON TWO LEADS, THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAYBE UNDERTAKEN TO ADDRESS THE ISSUE.
Description of Event or Problem · 0
SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 IN WHICH THE PATIENT'S SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 882895 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG SLIM TIP LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 6151565 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | DRG IPG| DRG LEAD |