FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2101734
·
Received May 10, 2011
Report
- Report Number
- 3004209178-2011-03367
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 9, 2011
- Report Date
- October 16, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 TURNED HIS BODY, FELT SOMETHING "NEGATIVE" HAPPEN WITH THE IMPLANTABLE NEUROSTIMULATOR, AND THEN EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND RETURN OF "SHARP STABBING" PAIN IN THE LOWER BACK WITH RECENT DIARRHEA EPISODES. THE PATIENT'S PROGRAMMER AND RECHARGER WERE CONFIRMED TO BE FUNCTIONING PROPERLY. THE PATIENT WAS SCHEDULED TO SEE THE HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Required Intervention | "SEE H10...."| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT # V574039017.| PROGRAMMER: MODEL 37743, LOT # NKE160644N.| PROGRAMMER: MODEL 37743, LOT # NKE160644N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT # V574039017 |