FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1890215
·
Received October 22, 2010
Report
- Report Number
- 3004209178-2010-08300
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 12, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD LOST THERAPEUTIC EFFECT FROM THEIR DEVICE. IT WAS STATED THE PT LOST EFFECT TWO DAYS AFTER IMPLANT. TROUBLESHOOTING SUGGESTED ADJUSTING THE DEVICE WITH THE PT PROGRAMMER. IT WAS STATED THERAPEUTIC EFFECT WAS RESTORED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 83 YR | IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA028061N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT # V012547| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT # V026984035| PROGRAMMER: MODEL 37742, LOT # NJD043209N| EXPLANTED:| LOT # UNK| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO,| EXPLANTED:| EXPLANTED:| IMPLANTED: |