FDA Adverse Event
Death
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1990054
·
Received February 9, 2011
Report
- Report Number
- 3004209178-2011-01001
- Event Type
- Death
- Date Received
- February 9, 2011
- Report Date
- January 25, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT WAS EXPERIENCING PAIN AT THE INS IMPLANT SITE. PATIENT VISITED HER DOCTOR AND THE MEDTRONIC REPRESENTATIVE REGARDING THE PAIN IN HER BUTTOCK AREA. SHE WAS REPROGRAMMED SUCCESSFULLY BUT THE PAIN CONTINUED. PATIENT HAD EXPRESSED THE DESIRE TO HAVE THE SYSTEM REMOVED. ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE SYSTEM WAS REMOVED ON (B)(6) 2010. PATIENT DIED OF PNEUMONIA AFTER REMOVAL OF HER SCS BATTERY. NO DATE OF DEATH OR IF IT WAS RELATED TO THE EXPLANT SURGERY WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
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 | Death | LEAD: MODEL 3778, LOT # V144380028| PROGRAMMER: MODEL 37743, LOT # NKE114932N| LEAD: MODEL 3778, LOT # V148127019| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED: |