FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 4192593
·
Received October 22, 2014
Report
- Report Number
- 3004209178-2014-20158
- Event Type
- Injury
- Date Received
- October 22, 2014
- Report Date
- September 30, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT REQUIRED COMPLETE SYSTEM REPLACEMENT. THE LEAD WAS REPLACED FOR PROBABLE LEAD DAMAGE APPROXIMATELY SIX MONTHS AFTER ROUTINE STIMULATOR EXCHANGE. NO PATIENT OUTCOME WAS REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672420 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |