FDA Adverse Event
Injury
Summary report: N
SYNERGY COMPACT
MDR report key: 2954723
·
Received February 11, 2013
Report
- Report Number
- 3004209178-2013-02480
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- March 29, 2007
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# J0537520V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT COVERING THEIR PAIN AND DID NOT MEET THEIR THERAPY EXPECTATIONS. IT WAS DETERMINED THAT THE LEAD COMPONENT OF THE INS SYSTEM HAD MIGRATED. THE INS SYSTEM WAS EXPLANTED AND NOT REPLACED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59412 | SYNERGY COMPACT | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7479B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00043 YR | Required Intervention |