FDA Adverse Event
Injury
Summary report: N
ENRHYTHM DR
MDR report key: 1803312
·
Received August 17, 2010
Report
- Report Number
- 2647346-2010-00476
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- October 1, 2009
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT 2 MONTHS AFTER IMPLANT, PATIENT STARTED FEELING PAIN IN LEGS. IT EVENTUALLY MOVED INTO ARMS. THE PATIENT HAS SEEN MEDICAL DOCTORS, CARDIOLOGIST, CHIROPRACTOR AND HAS HAD SEVERAL TESTS DONE TO DIAGNOSE THIS PAIN. THE PATIENT THINKS IT COULD BE THE PACEMAKER SINCE IT STARTED AFTER IMPLANT. THE PATIENT THINKS IT COULD POSSIBLY BE AN ALLERGIC REACTION TO THE DEVICE AS WELL. THE CARDIOLOGIST HAS RULED OUT THE PAIN BEING RELATED TO THE PACEMAKER IMPLANT. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENRHYTHM DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other | 5076 (X2) IMPLANTABLE PACING LEADS |