FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 3212505
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-08617
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- March 19, 2013
- Report Date
- September 28, 2016
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 1
AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE AUTO CAPTURE FEATURE HAD INCREASED BATTERY CONSUMPTION AND DECREASED THE ESTIMATED LONGEVITY. THE DEVICE REMAINS IN SERVICE WITH PROGRAMMING CHANGES. THERE WERE NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SITUATION WILL CONTINUE TO BE MONITORED WITH NO CHANGE AT THIS TIME.
Description of Event or Problem · 1
THE DEVICE WAS EXPLANTED OVER THREE YEARS LATER FOR REPORTED NORMAL BATTERY DEPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314410 | ALTRUA | IMPLANTABLE PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | S601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Hospitalization| L| R | 1198| S601| 4285 |