FDA Adverse Event
Injury
Summary report: N
CAPSURE
MDR report key: 2853708
·
Received December 3, 2012
Report
- Report Number
- 2182208-2012-04047
- Event Type
- Injury
- Date Received
- December 3, 2012
- Report Date
- November 20, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- DTB
- PMA / PMN Number
- P950024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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 PRODUCT: 4968 IMPLANTABLE PACING LEAD 2007 (B)(6). (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 RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE AND UNSUCCESSFUL PACING DUE TO A SUSPECTED LEAD FRACTURE. THE RV LEAD WAS 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 |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE | ELECTRODE, PACEMAKER, PERMANENT | DTB | RICE CREEK MFG | 4968-25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) |