FDA Adverse Event
Malfunction
Summary report: N
SURESCAN
MDR report key: 9488058
·
Received December 18, 2019
Report
- Report Number
- 3004209178-2019-24031
- Event Type
- Malfunction
- Date Received
- December 18, 2019
- Report Date
- December 18, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169109483
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE, REGARDING PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THEIR IPG. THE REP CALLED THE PATIENT AND LEFT A MESSAGE BUT HAVE NOT HEARD BACK. HCP HAD NO FURTHER INFORMATION. PATIENT'S WEIGHT WAS ASKED BUT UNKNOWN. NO SYMPTOMS WERE REPORTED. (B)(6) 2019, E1-E5 (REP): NNI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1283358 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |