FDA Adverse Event
Malfunction
Summary report: N
ATTAIN OTW
MDR report key: 4162542
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-12709
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- August 1, 2014
- Report Date
- August 1, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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. CONCOMITANT MEDICAL PRODUCTS: 6945-65 LEAD, IMPLANTED: (B)(6) 2000; 6940-52 LEAD, IMPLANTED: (B)(6) 2000. (B)(4). EVALUATION SUMMARY: UPON ANALYSIS, NO ANOMALIES WERE FOUND; FULL LEAD RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION IN ALL VECTORS. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643563 | ATTAIN OTW | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | D314DRG ICD |