FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 2203722
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-12600
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S38
- Removal / Correction Number
- ASKU
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD AN INSULATION BREAK AND AN OUTER CONDUCTOR FRACTURE, AND THAT BIPOLAR IMPEDANCES HAD BEEN HIGH AND THRESHOLDS HAD INCREASED. IT WAS ALSO REPORTED THAT THE LEAD WAS UNIPOLARIZED. THE LEAD WAS CAPPED AND ABANDONED AND REPLACED WITH A NEW LEAD. 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 SP NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5092 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Hospitalization| R | 5592 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |