FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1973646
·
Received January 18, 2011
Report
- Report Number
- 3004209178-2011-00411
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Report Date
- January 5, 2011
- 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
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT SHE EXPERIENCED WEAKNESS IN HER LEGS WHEN SHE TURNED THE AMPLITUDE UP. SHE WAS CHARGING MORE THAN SHE USED TO AND THE CHARGE WAS NOT LASTING AS LONG. THE RECHARGER BELT WAS BROKEN WHERE THE ANTENNA ATTACHES. THE HEALTH CARE PROVIDER CONFIRMED THAT THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2010. HER STIMULATOR DOES NOT WORK. SHE HAD A COUGHING SPELL AND BLACKED OUT. SHE WAS HOSPITALIZED FOR PNEUMONIA AND EMPHYSEMA. SHE EXPERIENCED UPPER EXTREMITY NUMBNESS TINGLING. HER SYMPTOMS WERE CONSISTENT WITH MYELORADICULOPATHY. CT MYELOGRAPHY OF THE THORACIC AND LUMBAR SPINE, PLAIN FILM X-RAYS WERE RECOMMENDED.
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 | EXTENSION: MODEL 37083, LOT# NKC016821N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# V113343| EXTERNAL DEVICE: MODEL 37751, LOT# UNK| PROGRAMMER: MODEL 37742, LOT# NJD065683N| ACCESSORY: MODEL 37752, LOT# NKA036692N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC016820N| IMPLANTED:| EXPLANTED:| EXPLANTED: |