FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME
MDR report key: 2022117
·
Received February 28, 2011
Report
- Report Number
- 3004209178-2011-01476
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 9, 2011
- 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
RECEIVED INFO THE PT PROGRAMMER SHOWED A "CALL YOUR DOCTOR" ICON. MANUFACTURER'S REP REPORTS AN OUT OF REGULATION CONDITION WHEN ADJUSTING PROGRAM #4. GROUP IMPEDANCE READINGS SHOWED A1-430, A2-451, A3-549, A4-XXX. RE-RAN AT A LOWER AMPLITUDE FOR PROGRAM 4 AND STILL NO READING, REP REMOVED 15 AND IMPEDANCES SHOWED <70 OHMS. ADDITIONAL READINGS SHOWED <70 OHMS ON ALL COMBINATIONS WITH ELECTRODE 12. REPROGRAMMING WAS DONE ON PROGRAM 4 NOT USING 12 AND RE-RAN GROUP IMPEDANCE WAS AT 576 OHMS. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | LEAD: MODEL 3777, LOT# V377181039| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V378498001| PROGRAMMER: MODEL 37743, LOT# NKE158755N| IMPLANTED:| EXPLANTED: |