FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 5142705
·
Received October 10, 2015
Report
- Report Number
- 2649622-2015-13252
- Event Type
- Injury
- Date Received
- October 10, 2015
- Date of Event
- August 7, 2015
- Report Date
- August 31, 2015
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P830061
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
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: PRODUCT ID: 4068-45 LEAD, IMPLANTED: (B)(6) 1999. (B)(4)
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THEIR LEADS WERE EXPLANTED AND REPLACED DUE TO BEING DAMAGED. FOLLOW UP WITH THE PATIENT'S CLINIC WAS UNSUCCESSFUL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673705 | CAPSURE SP | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 4024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | Hospitalization| R |