FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1890197
·
Received October 22, 2010
Report
- Report Number
- 3004209178-2010-08302
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 27, 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
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STIMULATION WAS IN THE WRONG LOCATION FOLLOWING A FALL. THE PT FELL DURING VACATION AND THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE WAS SWOLLEN AND FELT WARM. THE PT WAS TO SEE THE DR ON (B)(6) 2010. THE PT'S STATUS WAS UNK. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT # 3004209178-2010-08307
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | EXPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# J0519260V| PROGRAMMER: MODEL 37742, LOT# NJD057162N| LEAD: MODEL 3778, LOT# V001853| LEAD: MODEL 3888, LOT# V040902| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| MODEL 37713, LOT# NJK707661H| IMPLANTABLE NEURO STIMULATOR| PROGRAMMER: MODEL 37743, LOT# NKE125606N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU055193V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU055194V| LEAD: MODEL 3778, LOT# N0044827| ACCESSORY: MODEL 37752, LOT# NKA032158N| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB009665N| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB008824N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: |