FDA Adverse Event
Injury
Summary report: N
PATCH
MDR report key: 2183559
·
Received July 29, 2011
Report
- Report Number
- 2124215-2011-12791
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 2011
- Manufacturer
- HISTORICAL PUERTO RICO
- Product Code
- NHW
- PMA / PMN Number
- P830060
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE LEAD REMAINS SURGICALLY ABANDONED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SURGICAL AND MEDICAL INTERVENTION WAS PERFORMED TO REMOVE AN INFECTION IN A PATIENT WITH THIS PREVIOUSLY SURGICALLY ABANDONED LEAD. SURGICAL INTERVENTION WAS PERFORMED TO CLEAN THE INFECTION, HOWEVER THE PATIENT SYSTEM WAS NOT REVISED. THE PATIENT WAS ALSO GIVEN INTRAVENOUS MEDICATION TO HELP HEAL THE INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PATCH | IMPLANTABLE LEAD | NHW | HISTORICAL PUERTO RICO | 0040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| L| R | 0040| 1746| 1860| 1705| 0155| E102| 4320 |