FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 3930014
·
Received July 11, 2014
Report
- Report Number
- 2124215-2014-11676
- Event Type
- Injury
- Date Received
- July 11, 2014
- Date of Event
- May 26, 2014
- Report Date
- June 17, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD AND LOSS OF CAPTURE (LOC) THAT LED TO GREATER THAN TWO SECONDS ASYSTOLE. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED AND INDICATES THAT THIS PATIENT WAS ALSO HAVING A SHOULDER TWITCHES APPROXIMATELY 15-20 SECONDS. THE PHYSICIAN SUSPECTED INSULATION DAMAGED AND CAUSING SHOULDER TWITCHES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407748 | FLEXTEND | IMPLANTABLE LEAD | DTB | CPI - DEL CARIBE | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| L| R | 4087| 1298| 4086| S603 |