FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGER
MDR report key: 1001555
·
Received February 21, 2008
Report
- Report Number
- 2182207-2008-00832
- Event Type
- Injury
- Date Received
- February 21, 2008
- Date of Event
- January 1, 2008
- Report Date
- January 16, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE ANALYSIS REVEALED NO ANOMALIES; THE COMPLAINT COULD NOT BE VERIFIED.
Description of Event or Problem · 1
THE MFR REP REPORTED THE PATIENT RECEIVED A BURN OVER THE NEUROSTIMULATOR SITE TWO DAYS AFTER RECHARGING. THE RECHARGER WAS REPLACED. ADD'L INFO WAS REQUESTED FROM THE HEALTHCARE PROVIDER. THE HCP REPORTED WOUND/SUTURE DEHISCENCE OVER THE BURN AREA, INFECTION AND PRE-EXISTING PAIN. THE NEUROSTIMULATOR SITE WAS REVISED INCLUDING EXPLANTATION OF THE NEUROSTIMULATOR AND LEAD. THE NEUROSTIMULATOR WAS RELOCATED; THE HCP DOES NOT EXPECT FURTHER SEQUELA. REFER TO MEDWATCH REPORT # 3004209178200800833.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGER | LGW | MEDTRONIC NEUROMODULATION | 37751 | NKA031546N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention | EXTENSION: MODEL UNK, LOT # UNK| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3776, LOT# V047379| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37711| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# V016352| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V016352| LOT# NJH717213H| IMPLANTED:| IMPLANTED: |