FDA Adverse Event
Injury
Summary report: N
PRIMEADVANCED
MDR report key: 3021138
·
Received March 26, 2013
Report
- Report Number
- 3007566237-2013-00890
- Event Type
- Injury
- Date Received
- March 26, 2013
- Report Date
- March 8, 2013
- 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
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THE INS WAS REMOVED DUE TO ALLERGY OR INFECTION. IT WAS REPORTED THE LEADS WERE STILL IN PLACE AND THE HEALTH CARE PROVIDER (HCP) DOES NOT BELIEVE THE PATIENT WILL GET ANOTHER IMPLANTABLE NEUROSTIMULATOR SOON. IT WAS NOTED THERE WAS NO INJURY FOR THE PATIENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD AN INFECTION, WITH SYMPTOMS OF INCISIONAL WOUND OPENING/DRAINAGE. THE DEVICE WAS EXPLANTED AFTER FOUR AND A HALF MONTHS. THE OUTCOME WAS REPORTED THAT THE PATIENT WAS ALIVE AND WITHOUT INJURY OR ADVERSE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124596 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |