FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 1862168
·
Received October 8, 2010
Report
- Report Number
- 2124215-2010-15993
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- July 27, 2010
- Report Date
- February 5, 2016
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE UPDATED AS NECESSARY.
Additional Manufacturer Narrative · 1
THE RETURN OF THE PRODUCT WAS REQUESTED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS EVENT WOULD BE UPDATED UPON ANALYSIS COMPLETION.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A RECENT CLINIC VISIT, THE HEALTH CARE FACILITY STATED THAT THIS DEVICE WAS MALFUNCTIONING AND NOT WORKING. THEY STATED THAT THE DEVICE WAS PACING DURING THE QRS COMPLEXES. ATTEMPTS TO GAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. AT THIS TIME THE DEVICE REMAINS IN SERVICE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED THAT THIS PRODUCT WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | 1290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| L| R | 4244| 4035| 1290 |