FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 3864998
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-07568
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- December 9, 2013
- Report Date
- December 9, 2013
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 4024-58 IMPLANTABLE PACING LEAD: (B)(6) 1999. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS CAPPED/UNUSABLE AND REPLACED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339153 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4524-53 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Hospitalization| R | P1501DR IMPLANTABLE PULSE GENERATOR |