FDA Adverse Event
Malfunction
Summary report: N
PROCLAIM 5 ELITE
MDR report key: 8675151
·
Received June 6, 2019
Report
- Report Number
- 1627487-2019-06465
- Event Type
- Malfunction
- Date Received
- June 6, 2019
- Date of Event
- May 22, 2019
- Report Date
- July 25, 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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.
Additional Manufacturer Narrative · 1
INCLUDE FSCA VERBIAGE TO BE USED IN MDR AND MDV (11.2): THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) INACCURATE ELECTIVE REPLACEMENT INDICATOR ADVISORY NOTICE ISSUED BY ABBOTT ON 12 SEPTEMBER 2017.
Description of Event or Problem · 1
IT WAS REPORTED THAT DIAGNOSTICS INDICATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED EARLIER THAN INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470050 | PROCLAIM 5 ELITE | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3660 | 5636835 | 05415067020192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |