FDA Adverse Event
Malfunction
Summary report: N
SUBQ
MDR report key: 2192121
·
Received August 4, 2011
Report
- Report Number
- 2182208-2011-01081
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 21, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S021
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, 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. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE DEFIBRILLATION COIL WAS DISTORTED. IT WAS NOTED THAT THE LEAD APPEARED DAMAGE AT IMPLANT.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE COIL WAS BENT AND THE LEAD WAS POSSIBLY DAMAGED. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBQ | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6996 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Other |