FDA Adverse Event
Injury
Summary report: N
CRYSTALLINE
MDR report key: 1921365
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-12487
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 3, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S034
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 PATIENT CAME TO THE EMERGENCY ROOM WITH SYNCOPE. THE VENTRICULAR LEAD IMPEDANCES WERE HIGH AND NOISE WAS REPRODUCIBLE WITH ARM MOVEMENT. IT WAS FURTHER REPORTED THAT CLAVICLE CRUSHING OF THE LEAD WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALLINE | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | ICM09B | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |