FDA Adverse Event
Death
Summary report: N
CAPSURE SP
MDR report key: 1984186
·
Received February 10, 2011
Report
- Report Number
- 2649622-2011-00221
- Event Type
- Death
- Date Received
- February 10, 2011
- Date of Event
- May 7, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S15
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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, DISTAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION. FULL LEAD RETURNED AND ANALYZED.
Description of Event or Problem · 1
THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. IT WAS REPORTED THE PATIENT DIED WITH CAUSE OF DEATH NOTED TO BE ADENOCYSTIC CARCINOMA WITH METASTASES. ADDITIONAL INFORMATION IS BEING REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE SP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5024M | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Death | (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |