FDA Adverse Event
Injury
Summary report: N
CAPSUREFIX NOVUS
MDR report key: 2203712
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-12368
- Event Type
- Injury
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P930039/S009
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. EVALUATION SUMMARY FOR (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE OUTER INSULATION WAS BREACHED CUT, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON ROUTINE CHECK, THE RIGHT VENTRICULAR LEAD IMPEDANCES WERE FOUND TO BE HIGH AND WERE GREATER THAN 9000 OHMS. THE LEAD HAD AN APPARENT FRACTURE. THE LEAD WAS 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 |
|---|---|---|---|---|---|---|---|
| 1 | CAPSUREFIX NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5076 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD |