FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1576848
·
Received January 8, 2010
Report
- Report Number
- 3004209178-2010-00180
- Event Type
- Malfunction
- Date Received
- January 8, 2010
- Date of Event
- December 15, 2009
- Report Date
- December 15, 2009
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4)
Description of Event or Problem · 1
IT WAS REPORTED THE INTRA-OPERATIVE IMPEDANCE READINGS WERE >4000 OHMS ON ELECTRODE 4-7. ELECTRODES 0-3 WERE WITHIN NORMAL RANGE. REP REPORTED RUNNING ELECTRODE IMPEDANCE TEST WERE RUN AT THE DEFAULT VALUE. THE AMPLITUDE WAS INCREASED TO 3.0V AND RE-TESTED. ALL IMPEDANCES VALUES WERE THEN WITHIN NORMAL RANGES FROM 900-1900 OHMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | LEAD: MODEL 3890, LOT# J0331973V| EXPLANTED:| EXPLANTED:| IMPLANTED:| ADAPTER: MODEL 74002, LOT# UNKNOWN| EXTENSION: MODEL 7489, LOT# NHU012250V| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU012247V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3890, LOT# J0331973V| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: |