FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEUROSTIMULATOR
MDR report key: 2161991
·
Received July 11, 2011
Report
- Report Number
- 3007566237-2011-05263
- Event Type
- Injury
- Date Received
- July 11, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 15, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT BUTTOCK PAIN AND ERYTHEMA AROUND THE WOUND. THE PATIENT WAS DIAGNOSED WITH (B)(6). THE PATIENT ALSO DEVELOPED A (B)(6) AT THE SURGICAL SITE. THE LEAD WAS EXPLANTED ON (B)(6) 2011 AND THE PATIENT RECEIVED INTRAVENOUS AND ORAL ANTIBIOTICS. THE PATIENT'S STATUS WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN NEUROSTIMULATOR | LGW | MEDTRONIC NEUROMODULATION | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | UNK. |