OCTRODE LEAD KIT, 60CM LENGTH
Report
- Report Number
- 1627487-2023-01693
- Event Type
- Injury
- Date Received
- April 12, 2023
- Date of Event
- February 21, 2023
- Report Date
- July 17, 2023
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- UDI-DI
- 05415067017246
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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.
EXACT DATE OF EVENT IS UNKNOWN. THE ALLEGATION IS AGAINST 1 OF 2 LEADS HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL:3186 , UDI:(B)(4) , SERIAL: (B)(4), BATCH:8031725 DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION.
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE LEAD WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED POST-OPERATIVELY.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO HIGH IMPEDANCES ON THEIR LEAD. IT IS UNCLEAR WHICH LEAD CONTRIBUTED TO THE ISSUE. SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2258009 | OCTRODE LEAD KIT, 60CM LENGTH | PERCUTANEOUS LEAD | LGW | ABBOTT MEDICAL | 3186 | 8031725 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other | SCS ANCHOR (X2)| SCS IPG |