FDA Adverse Event
Injury
Summary report: N
CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US
MDR report key: 6641670
·
Received June 14, 2017
Report
- Report Number
- 2938836-2017-29107
- Event Type
- Injury
- Date Received
- June 14, 2017
- Date of Event
- May 18, 2017
- Report Date
- January 17, 2019
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVZ
- PMA / PMN Number
- P910023
- Removal / Correction Number
- Z-0115-2017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PREMATURE BATTERY DEPLETION WAS CONFIRMED BY ANALYSIS. NO SOURCES OF HIGH CURRENT WERE NOTED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS CONSISTENT WITH LI CLUSTER FORMATION. FROM THESE ANALYSES, IN THE ABSENCE OF HIGH CURRENT DRAW, IT IS PROBABLE THAT THE PREMATURE BATTERY DEPLETION WAS CAUSED BY A LITHIUM CLUSTER INDUCED SHORT CIRCUIT. LI CLUSTERS ARE A KNOWN DEPLETION MECHANISM FOR THESE ADVISORY PRODUCTS THAT HAS BEEN INVESTIGATED AND ASSOCIATED WITH A FIELD ACTION IN OCTOBER 2016. CORRECTION: - PMA/510(K) NUMBER SHOULD HAVE BEEN P910023 RATHER THAN BLANK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED INTO OFFICE FOR A NORMAL FOLLOW-UP, SHOWING THE DEVICE HAD REACHED ERI PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421560 | CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NVZ | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2257-40Q | 3888204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |