FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 12697591
·
Received October 26, 2021
Report
- Report Number
- 3006705815-2021-05276
- Event Type
- Injury
- Date Received
- October 26, 2021
- Date of Event
- October 12, 2021
- Report Date
- January 11, 2022
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
- Product Code
- LGW
- UDI-DI
- 05415067017246
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT HAD THEIR SYSTEM EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED.
Additional Manufacturer Narrative · 1
DATE OF THE EVENT IS ESTIMATED.
Description of Event or Problem · 1
RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2021-05277. IT WAS REPORTED THE PATIENT IS EXPERIENCING A ZAPPING SENSATION WITH THEIR STIMULATION DUE TO HIGH IMPEDANCES. AS A RESULT, THE PATIENT HAS INEFFECTIVE STIMULATION. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1593892 | OCTRODE LEAD KIT, 60CM LENGTH | PERCUTANEOUS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) | 3186 | A000108322 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other | MODEL # 3660 - IPG.| MODEL # 3660 - IPG |