QUATTRODE LEAD WIDE SPACED, 90 CM
Report
- Report Number
- 1627487-2025-03562
- Event Type
- Injury
- Date Received
- July 21, 2025
- Date of Event
- June 9, 2025
- Report Date
- September 23, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- UDI-DI
- 05414734406116
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: QUATTRODE, MODEL: 3169, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6042358.
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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.
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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.
IT WAS REPORTED THE PATIENT'S LEFT OCCIPITAL LEAD HAD HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE. NOTE : IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS ISSUE.
ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT HAD INEFFECTIVE THERAPY DUE TO BOTH OCCIPITAL LEADS HAD HIGH IMPEDANCE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEADS WERE EXPLANTED AND REPLACED. EFFECTIVE THERAPY RESTORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2732070 | QUATTRODE LEAD WIDE SPACED, 90 CM | SCS LEAD | LGW | ABBOTT MEDICAL | 3169 | 6042358 | 05414734406116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | SCS ADAPTERX2.| SCS ANCHORX2.| SCS IPG.| SCS LEADX3. |