FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 3922010
·
Received July 9, 2014
Report
- Report Number
- 2124215-2014-13617
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- June 6, 2014
- Report Date
- July 9, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND PATIENT EXPERIENCING PAIN. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT REMAINS IN SERVICE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401947 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | 1291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| L| R | 432-03| 1291| 294-23E| 430-07 |