FDA Adverse Event
Death
Summary report: N
TARGET TIP
MDR report key: 1724601
·
Received June 16, 2010
Report
- Report Number
- 2649622-2010-06832
- Event Type
- Death
- Date Received
- June 16, 2010
- Date of Event
- July 1, 2001
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K822781
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B) (4) OUTER INSULATION SEPARATION. PROXIMAL SEGMENT RETURNED AND ANALYZED.
Description of Event or Problem · 1
THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, WAS ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET TIP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4011 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Death | 8427 IMPLANTABLE PULSE GENERATOR |