FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX LEAD
MDR report key: 3993074
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09505
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 26, 2014
- Report Date
- June 14, 2019
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: 6932-58 LEAD IMPLANTED: (B)(6) 1999; 5076-52 LEAD IMPLANTED: (B)(6) 2012. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PASSED OUT. UPON INTERROGATION, 10 ATRIAL FIBRILLATION DETECTIONS WERE NOTED, WITH VERY RANDOM/INTERMITTENT ATRIAL OVERSENSING OF POSSIBLE NOISE/MYOPOTENTIALS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THE RIGHT ATRIAL (RA) LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467051 | CAPSUREFIX LEAD | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6940-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | Hospitalization| L| R | (B)(4) ICD |