FDA Adverse Event
Injury
Summary report: N
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
MDR report key: 17969030
·
Received October 19, 2023
Report
- Report Number
- 1627487-2023-04952
- Event Type
- Injury
- Date Received
- October 19, 2023
- Date of Event
- October 4, 2023
- Report Date
- October 19, 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 THE EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6940462. BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.
Description of Event or Problem · 0
PATIENT REPORTED SHE HAD FALLEN AND THE SYSTEM WAS DISLODGED. AS SUCH, THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD HAD DISLODGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 91248 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 6940462 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | DRG IPG.| DRG LEAD. |