FDA Adverse Event
Injury
Summary report: N
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
MDR report key: 3056817
·
Received April 13, 2013
Report
- Report Number
- 2649622-2013-04991
- Event Type
- Injury
- Date Received
- April 13, 2013
- Date of Event
- February 21, 2013
- Report Date
- February 21, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. CONCOMITANT PRODUCTS: D314DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB (B)(6) 2012; 456853 IMPLANTABLE PACING LEAD (B)(6) 2001-09-06. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD ALERT HAD BEEN TRIGGERED. STORED EGMS (ELECTROGRAMS) SUGGEST NOISE OR OVERSENSING IN RV PACE/SENSE CHANNEL. WHEN PATIENT WAS IN THE OFFICE, AGGRESSIVE POCKET MANIPULATION DID CREATE A FEW OVERSENSING ARTIFACTS. POSSIBLE FRACTURE OF THE LEAD IS SUSPECTED. THE LEAD HAS BEEN EXPLANTED 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 |
|---|---|---|---|---|---|---|---|
| 159959 | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6945-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| R |