FDA Adverse Event
Injury
Summary report: N
POLYROX PX 60-UP
MDR report key: 2151535
·
Received June 27, 2011
Report
- Report Number
- 1028232-2011-01436
- Event Type
- Injury
- Date Received
- June 27, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 23, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUS MDR.
Additional Manufacturer Narrative · 1
THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE CUTTINGS IN THE INSULATION OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.
Description of Event or Problem · 1
OUS MDR - TWO DISLODGEMENTS WERE REPORTED ON THE DAY OF THE IMPLANTATION. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLYROX PX 60-UP | PACER LEAD | DTB | BIOTRONIK SE & CO. KG | 118523 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |