FDA Adverse Event
Injury
Summary report: N
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
MDR report key: 16883634
·
Received May 6, 2023
Report
- Report Number
- 1627487-2023-02097
- Event Type
- Injury
- Date Received
- May 6, 2023
- Date of Event
- March 28, 2023
- Report Date
- June 22, 2023
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027153
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Additional Manufacturer Narrative · 0
DATE OF EVENT ESTIMATED. ADDITIONAL COMPONENT POTENTIALLY INVOLVED IN THE EVENT INCLUDES: COMMON DEVICE NAME: DRG LEAD, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 7982307.
Description of Event or Problem · 0
IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS IS EXHIBITING HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE LEADS ATTRIBUTED TO THE EVENT.
Description of Event or Problem · 0
SURGICAL INTERVENTION WAS UNDERTAKEN IN WHICH THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474641 | KIT IMPLANTABLE SLIM TIP LEAD, 50CM | DRG SLIM TIP LEAD | PMP | ABBOTT MEDICAL | MN10450-50A | 7597646 | 05415067027153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | DRG IPG (X1)| DRG LEAD (X1) |