FDA Adverse Event
Injury
Summary report: N
CURRENT RF DR
MDR report key: 3901026
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12681
- Event Type
- Injury
- Date Received
- June 30, 2014
- Date of Event
- April 15, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF AN INABILITY TO COMMUNICATE WITH THE DEVICE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO PREMATURE BATTERY DEPLETION. DEVICE LEVEL TESTING WITH AN EXTERNAL POWER SUPPLY INDICATED NORMAL ELECTRICAL PERFORMANCE. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND ANALYSIS COULD NOT CONCLUSIVELY DETERMINE A ROOT CAUSE FOR THE PREMATURE BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC WITH A DEVICE THAT FAILED TO INTERROGATE. AFTER MULTIPLE ATTEMPTS, TELEMETRY COULD NOT BE ESTABLISHED AND IT WAS SUSPECTED THE DEVICE WENT PREMATURELY INTO END OF SERVICE. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380594 | CURRENT RF DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | 2207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |