FDA Adverse Event
Injury
Summary report: N
SPECTRAFLEX
MDR report key: 3160459
·
Received June 10, 2013
Report
- Report Number
- 2182208-2013-01835
- Event Type
- Injury
- Date Received
- June 10, 2013
- Report Date
- April 26, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- DTB
- PMA / PMN Number
- K790074
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. (B)(4).
Description of Event or Problem · 1
NO FURTHER INFORMATION WAS OBTAINED THROUGH FOLLOW-UP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED DUE TO AN UNKNOWN MALFUNCTION, THEN PARTIALLY REMOVED AT A LATER DATE. FOLLOW UP IS CURRENTLY IN PROCESS FOR ADDITIONAL INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259567 | SPECTRAFLEX | ELECTRODE, PACEMAKER, PERMANENT | DTB | RICE CREEK MFG | 697158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 5985 IMPLANTABLE PULSE GENERATOR (IPG) |