OCTRODE LEAD KIT, 60CM LENGTH
Report
- Report Number
- 1627487-2024-12857
- Event Type
- Injury
- Date Received
- December 26, 2024
- Date of Event
- December 5, 2024
- Report Date
- April 22, 2025
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
- Product Code
- LGW
- UDI-DI
- 05415067017246
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTED DATA: PER THE DEVICE INFORMATION RECEIVED (D4), THE MANUFACTURING SITE IN D3 AND G1 SHOULD HAVE BEEN ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) AND MFR NUMBER 1 SHOULD HAVE BEEN ¿3006705815¿ INSTEAD OF ¿1627487¿.
DATE OF EVENT IS ESTIMATED. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE DEVICE INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
THE REPORT EVENT OF HIGH IMPEDANCE WAS CONFIRMED. AS RECEIVED, MICROSCOPIC INSPECTION OF THE RETURNED LEAD FOUND A KINK ON THE OUTER TUBING AND ALL INTERNAL WIRES WERE BROKEN FROM STIM END.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. IMPEDANCE CHECK REVEALED HIGH IMPEDANCES ON ALL CONTACTS. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE LEAD WAS EXPLANTED AND REPLACED RESOLVING THE ISSUE. REPORTEDLY, EFFECTIVE THERAPY WAS RESTORED POST OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2433946 | OCTRODE LEAD KIT, 60CM LENGTH | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3186 | A000152230 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |