FDA Adverse Event
Injury
Summary report: N
PROMOTE PLUS CRT-D, DF4 CONNECTOR
MDR report key: 3220366
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04517
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 31, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
ANALYSIS DID NOT CONFIRM THE PREMATURE BATTERY DEPLETION. BASED ON DEVICE SETTINGS, A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE WITHIN EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP, EXCESSIVE BATTERY DEPLETION WAS OBSERVED. THE DEVICE WAS REPROGRAMMED. THE PATIENT WILL BE MONITORED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT DEVICE CHANGE OUT TO BE SCHEDULED FOR (B)(6) 2016.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320505 | PROMOTE PLUS CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |