FDA Adverse Event
Injury
Summary report: N
QUATTRODE LEAD WIDE SPACED, 60 CM
MDR report key: 22845897
·
Received August 19, 2025
Report
- Report Number
- 1627487-2025-04112
- Event Type
- Injury
- Date Received
- August 19, 2025
- Date of Event
- August 1, 2025
- Report Date
- September 22, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.
Additional Manufacturer Narrative · 0
DATE OF EVENT IS ESTIMATED.
Description of Event or Problem · 0
ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT ONLY THE L SO LEAD ERODED. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. INVESTIGATION WAS UNABLE TO DETERMINE WHICH LOT WAS THE LEFT LEAD.
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT'S LEADS ARE CAUSING SORENESS DUE TO EROSION. THERE IS NO CONCERN OF INFECTION. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436127 | QUATTRODE LEAD WIDE SPACED, 60 CM | SCS LEAD | LGW | ABBOTT MEDICAL | 3166 | 3769877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | SCS ADAPTERX2| SCS IPG |