FDA Adverse Event
Injury
Summary report: N
NONE
MDR report key: 1921511
·
Received December 13, 2010
Report
- Report Number
- 2182208-2010-00930
- Event Type
- Injury
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTD
- PMA / PMN Number
- K911302
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
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) THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION, THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE FULL LEAD WAS RETURNED AND ANALYZED.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | IMPLANTABLE LEAD ADAPTOR | DTD | MEDTRONIC, INC. | 586640M | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization| R | 6966 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE LEAD ADAPTOR| 6963 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |