FDA Adverse Event
Injury
Summary report: N
CAPSURE SP NOVUS
MDR report key: 1921318
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-12454
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 8, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S38
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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: (B)(4) NO ANOMALIES FOUND; FULL LEAD WAS RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD FIXATION DIFFICULTY AND DISLODGED FOLLOWING IMPLANT, SHOWED HIGH THRESHOLDS AND INTERMITTENT CAPTURE. THE LEAD WAS EXPLANTED 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 | CAPSURE SP NOVUS | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5092 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| R | SESR01 IMPLANTABLE PACEMAKER/CARDIO/DEFIB |