FDA Adverse Event
Injury
Summary report: N
PENTA 3MM LEAD, 60 CM
MDR report key: 10624887
·
Received October 5, 2020
Report
- Report Number
- 1627487-2020-31798
- Event Type
- Injury
- Date Received
- October 5, 2020
- Date of Event
- September 2, 2020
- Report Date
- October 4, 2020
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 05414734406246
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. 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 · 1
IT WAS REPORTED THAT HIGH IMPEDANCE WAS DISCOVERED ON MULTIPLE CONTACTS ON PATIENT'S LEAD DURING AN ELECTIVE IPG REPLACEMENT ON (B)(6) 2020. (REFERENCE REG REPORT: PER-2020-0172986) TROUBLESHOOTING WAS NOT ABLE TO RESOLVE THE ISSUE. THEREAFTER, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2020 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1093234 | PENTA 3MM LEAD, 60 CM | SCS PADDLE LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 4737767 | 05414734406246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |