FDA Adverse Event
Malfunction
Summary report: N
TRANSVENE SVC/CS
MDR report key: 2141873
·
Received June 28, 2011
Report
- Report Number
- 2182208-2011-01050
- Event Type
- Malfunction
- Date Received
- June 28, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980050/S1
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD IMPEDANCE WAS HIGH. THE LEAD MAY HAVE A POTENTIAL FRACTURE AND THE PATIENT HAS TWIDDLER'S SYNDROME. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSVENE SVC/CS | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6937A | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Other | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6937A IMPLANTABLE TACHY LEAD| 4968 IMPLANTABLE PACING LEAD |