FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 2790934
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14475
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 LEAD HAD HIGH IMPEDANCE AND NOISE. THE LEAD WAS RE-SEATED IN THE HEADER AND THEN THE FOLLOWING DAY, THE LEAD INTEGRITY ALERT TRIPPED FOR NON-SUSTAINED EPISODES AND NOISE WITH HIGH IMPEDANCE. POCKET MANIPULATION PRODUCED VARIED IMPEDANCES WITH NOISE NOTED. THE LEAD WAS CAPPED AND 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 | SPRINT QUATTRO | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R | 5568 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |