FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 2130897
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10294
- Event Type
- Injury
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S15
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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, HOWEVER THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION AND AN OUTER INSULATION COSMETIC DEPRESSION; PROXIMAL SEGMENT RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THE VENTRICULAR LEAD WAS REPLACED DUE TO A FRACTURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAPSURE SP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 5024M | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Hospitalization| R | SDR303 IMPLANTABLE PULSE GENERATOR| 4058M IMPLANTABLE PACING LEAD |