FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 1050040
·
Received May 8, 2008
Report
- Report Number
- 2649622-2008-02577
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- July 10, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- INVALID DATA
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. EVALUATION SUMMARY: OUTER INSULATION BREACHED; FULL LEAD IN SEGMENTS RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THE LEAD WAS CAPPED AND REPLACED DUE TO DECREASING IMPEDANCES AND AN APPARENT INSULATION BREAK. THE LEAD WAS SUBSEQUENTLY RETURNED WITH A REPORT OF LOW IMPEDANCE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE SP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4024 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention | 4068 IMPLANTABLE PACING LEAD| KDR401 IMPLANTABLE PULSE GENERATOR |