FDA Adverse Event
Malfunction
Summary report: N
ASKU
MDR report key: 1925529
·
Received December 14, 2010
Report
- Report Number
- 2182208-2010-00999
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- October 4, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003/S70
- Removal / Correction Number
- ASKU
- 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): NO ANOMALIES WERE FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT IMPLANT, THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE. IT WAS ALSO REPORTED THAT AFTER FURTHER EVALUATION, IT WAS IDENTIFIED THAT THE ADAPTER HAD FAILED. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | INSTRUMENT CABLE ADAPTOR | LWP | MEDTRONIC, INC. | 5103 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Other |