FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2172600
·
Received July 20, 2011
Report
- Report Number
- 3007566237-2011-05600
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 24, 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
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED IRRITATION AND INFLAMMATION AT THE POCKET SITE FOLLOWING IMPLANT. THE PT ALSO EXPERIENCED REDNESS, ITCHING, AND SKIN NECROSIS. AN ALLERGY TEST REVEALED THE PT WAS ALLERGIC TO MEDICAL ADHESIVE AND TITANIUM. THE PHYSICIAN STATED THE PT ALSO SHOWED A CONTACT ALLERGY TO DIPHENYLGUANIDINE AND PROPOLIS. THE PT UNDERWENT A SCAR REVISION AND NECROTIC TISSUE WAS REMOVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2011. THE DEVICE HAD BEEN PROVIDING 80% PAIN RELIEF. FOLLOWING EXPLANT, THE PT RECOVERED FROM THE ALLERGIC REACTION, THE WOUND WAS HEALING AND REDNESS HAD DISAPPEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MEDTRONIC NEUROMODULATION | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083-60, LOT# UNK |