FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 3862047
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07095
- Event Type
- Injury
- Date Received
- June 10, 2014
- Report Date
- April 8, 2014
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
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. CONCOMITANT MEDICAL PRODUCTS: A 4524 LEAD, IMPLANTED: (B)(6) 1999. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WARNING TRIGGERED, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS WITH A LOSS OF CAPTURE AND LOW IMPEDANCES. ADDITIONALLY, THE PATIENT EXPERIENCED POCKET STIMULATION WHEN THE LEAD WAS PROGRAMMED TO HIGH OUTPUTS. THE LEAD WILL BE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342804 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Hospitalization| R | ADDR01 IPG |