FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 6005831
·
Received October 6, 2016
Report
- Report Number
- 2649622-2016-11537
- Event Type
- Injury
- Date Received
- October 6, 2016
- Date of Event
- August 26, 2016
- Report Date
- August 27, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: 419488, LEAD, IMPLANTED: (B)(6) 2005; DTBB1D1 ICD, IMPLANTED: (B)(6) 2016.
Additional Manufacturer Narrative · 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REMOTE MONITORING TRANSMISSION WAS SENT DUE TO THE PATIENT EXPERIENCING SYNCOPE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 657512 | CAPSURE SP NOVUS | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5592-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Life Threatening | 694965 LEAD |