FDA Adverse Event
Death
Summary report: N
MERLIN@HOME, RF TELEMETRY BASIC
MDR report key: 6054789
·
Received October 25, 2016
Report
- Report Number
- 2938836-2016-13213
- Event Type
- Death
- Date Received
- October 25, 2016
- Report Date
- August 9, 2017
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- DRG
- PMA / PMN Number
- P030054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL, NO ANOMALY WAS FOUND.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE PATIENT EXPIRED ON JUNE 2, 2016 DUE TO A CARDIAC ARREST. SHE IS CONCERNED THAT THERE MAY HAVE BEEN AN ISSUE WITH THE TRANSMISSION(S) AND/OR THE FUNCTION OF THE ICD. THE ICD WAS EXPLANTED AND WAS INTERROGATED AFTER THE PATIENT PASSING. THE PHYSICIAN ALLEGEDLY REPORTED ¿FAINT HANDSHAKE¿ BETWEEN THE DEVICE AND TRANSMITTER AND THAT THERE WAS INTERMITTENT COMMUNICATION WITH THE TRANSMITTER SINCE IMPLANT. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 704606 | MERLIN@HOME, RF TELEMETRY BASIC | PACEMAKER DATA TRANSMITTER | DRG | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | EX1150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | (B)(4)| (B)(4)| (B)(4)| (B)(4) |