FDA Adverse Event
Malfunction
Summary report: N
PROCLAIM 5 ELITE
MDR report key: 8416990
·
Received March 13, 2019
Report
- Report Number
- 1627487-2019-03393
- Event Type
- Malfunction
- Date Received
- March 13, 2019
- Date of Event
- February 19, 2019
- Report Date
- March 13, 2019
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 05415067020192
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487/09/12/2017/001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INCLUDE (B)(4) VERBIAGE TO BE USED IN MDR AND MDV. THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) INACCURATE ELECTIVE REPLACEMENT INDICATOR ADVISORY NOTICE ISSUED BY (B)(4) ON (B)(6) 2017.
Description of Event or Problem · 1
IT WAS REPORTED THAT DIAGNOSTICS INDICATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED EARLIER THAN INTENDED. THE DEVICE HAS THE APPROPRIATE LEVEL OF BATTERY VOLTAGE TO PROVIDE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 208915 | PROCLAIM 5 ELITE | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3660 | 5752269 | 05415067020192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |