FDA Adverse Event
Malfunction
Summary report: N
INGENIO
MDR report key: 4221000
·
Received November 3, 2014
Report
- Report Number
- 2124215-2014-18390
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- September 26, 2014
- Report Date
- September 26, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PHYSICIAN COMPLAINED THAT THE STATUS OF THE BATTERY FELL RELATIVELY FAST. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703011 | INGENIO | IMPLANTABLE PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | J063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4459| J063| 4471 |