FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1822618
·
Received August 27, 2010
Report
- Report Number
- 3004209178-2010-06514
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- June 1, 2010
- Report Date
- July 30, 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
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
AT IMPLANTABLE NEUROSTIMULATOR REPLACEMENT SURGERY THE DOCTOR TRIED TO UNSCREW THE LEFT SIDE EXTENSION. SOME OF THE EXTENSION CONTACTS REMAINED IN THE NEUROSTIMULATOR (SEE MFG REPORT # 3004209178201005374). A WEEK AFTER REPLACEMENT SURGERY, THE PT FELT NO STIMULATION SENSATION. THE PT HAD WAITED 1 WEEK AFTER SURGERY TO RECHARGE HER NEW DEVICE. WHEN SHE TRIED TO DO SO, SHE WAS UNABLE TO MAKE A CONNECTION WITH THE PT PROGRAMMER OR RECHARGER. A SECOND REVISION SURGERY WAS SCHEDULED FOR (B)(6)2010. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED 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 | 46 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 3778, LOT # N0037165| LOT # NJH701398H| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37711,| ACCESSORY: MODEL 37752, LOT # NKA138137N| PROGRAMMER: MODEL 37743, LOT # NKE148851N| PROGRAMMER: MODEL 37742, LOT # NJD010285N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU075315V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU065475V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT # N0037161| EXPLANTED: |