FDA Adverse Event
Malfunction
Summary report: N
ENERGEN ICD
MDR report key: 3760893
·
Received April 21, 2014
Report
- Report Number
- 2124215-2014-08844
- Event Type
- Malfunction
- Date Received
- April 21, 2014
- Date of Event
- May 15, 2012
- Report Date
- May 25, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- UDI-DI
- 00802526480713
- PMA / PMN Number
- P960040/S235
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
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
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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED A PACING IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. NO ADVERSE EVENTS HAVE BEEN REPORTED. THE DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS SYSTEM HAS BEEN EXHIBITED RISING SHOCK IMPEDANCE AND THRESHOLD MEASUREMENTS OVER THE PAST FEW YEARS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239705 | ENERGEN ICD | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | E140 | 101994 | 00802526480713 |
| 239719 | ENERGEN ICD | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | E140 | 101994 | 00802526480713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | 0286| E140| E140| 0286 |