FDA Adverse Event
Injury
Summary report: N
SUBQ
MDR report key: 1792307
·
Received August 10, 2010
Report
- Report Number
- 2182208-2010-00442
- Event Type
- Injury
- Date Received
- August 10, 2010
- Date of Event
- April 11, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S021
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 PATIENT ALERT WAS TRIGGERED FOR SUPERIOR VENA CAVA (SVC) IMPEDANCE GREATER THAN 200OHMS. PRIOR TO 11APR THE SVC TREND WAS 50OHMS. THE CAN TO SVC ELECTROGRAM HAS SOME NOISE ON IT WHICH WAS NOTED AS "PROBABLY MUSCLE NOISE". THE COMPANY'S TECHNICAL SERVICES CONSULTANT DISCUSSED TESTING FOR LEAD FRACTURE. POCKET MANIPULATION AND ISOMETRICS WHILE DOING IMPEDANCE MEASUREMENTS SHOWED NO CHANGE. THE CLINICIAN IS PLANNING TO REVISE THE LEAD. RECORDS INDICATE THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE 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 | 58 YR | Other | D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD |