FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 3840976
·
Received May 30, 2014
Report
- Report Number
- 3004209178-2014-09907
- Event Type
- Injury
- Date Received
- May 30, 2014
- Report Date
- May 9, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS OF THE NEUROSTIMULATOR, SERIAL #(B)(4), FOUND IT FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES. ANALYSIS OF THE LEADS, SERIAL #(B)(4) FOUND THE DISTAL END FIXATION LOOP DETACHED. THERE WAS NO SIGNIFICANT ANOMALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD NO RESPONSE TO THE TREATMENT. THE DEVICE ERODED THROUGH THE SKIN AND WAS EXPLANTED. THE PATIENT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317854 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |