FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2223858
·
Received August 18, 2011
Report
- Report Number
- 3004209178-2011-06515
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 29, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 PT HAD "RED AND BROWN MARKS" ON THE BACK, AROUND THE IMPLANTABLE NEUROSTIMULATOR SITE. THE PT ALSO HAD "BLACK STUFF OOZE" FROM THE BACK, AND HAD AN OPENING IN THE BACK AROUND THE DEVICE SITE. THE LEADS ALWAYS CAUSED THE PT PAIN. NO INFO WAS PROVIDED RELATED TO THE PT'S OUTCOME. ADD'L INFO WAS REQUESTED BUT NOT AVAILABLE AS THE DATE OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Required Intervention| O | EXPLANTED: | IMPLANTED: | LEAD: MODEL 39565-65, LOT# V473239039| PROGRAMMER: MODEL 37743, LOT# NKE147088N| PROGRAMMER: MODEL 37743, LOT# NKE157345N| RECHARGER: MODEL 37752, LOT# NKA129093N| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE147088N| LEAD: MODEL 39565-65, LOT# V473239039| PROGRAMMER: MODEL 37743, LOT# NKE157345N| RECHARGER: MODEL 37752, LOT# NKA129093N |