FDA Adverse Event
Injury
Summary report: N
MICRONY K SR
MDR report key: 4573954
·
Received March 5, 2015
Report
- Report Number
- 2017865-2015-03296
- Event Type
- Injury
- Date Received
- March 5, 2015
- Date of Event
- December 22, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWP
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO ARRIVING TO THE HOSPITAL, THE PATIENT WAS FOUND UNCONSCIOUS AND HAD TO BE RESUSCITATED. THE PATIENT WAS TAKEN TO THE HOSPITAL AND BRAIN DAMAGE WAS SUSPECTED. IN THE HOSPITAL, THE ELECTROCARDIOGRAM SHOWED THAT THE PULSE GENERATOR EXHIBITED INAPPROPRIATE RATE INCREASE. IT WAS SPECULATED THAT THERE WAS INTERFERENCE BETWEEN THE DEVICE AND THE BACLOFEN PUMP. NO INTERVENTION WAS REPORTED. THE PATIENT WOULD BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153811 | MICRONY K SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC., CRMD | 2535K | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Hospitalization| S |