FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3170862
·
Received June 14, 2013
Report
- Report Number
- 3006630150-2013-01226
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- May 22, 2013
- Report Date
- May 22, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION WILL BE PROVIDED TO BSN.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS RELOCATED AS THE PATIENT DID NOT LIKE ITS LOCATION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WILL BE RELOCATED. THE REASON FOR THE PROCEDURE WAS UNKNOWN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WILL BE RELOCATED. THE REASON FOR THE PROCEDURE WAS UNKNOWN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WILL BE RELOCATED. THE REASON FOR THE PROCEDURE WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271592 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |