ADAPTA SR
Report
- Report Number
- 6000144-2010-03060
- Date Received
- August 10, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
THE PATIENT'S MOTHER REPORTED THAT THE DEVICE SOUNDS LIKE IT HAS AN ALARM IN IT, AND GOES OFF AT DIFFERENT TIMES OF THE DAY. THE PATIENT'S MOTHER FURTHER REPORTED THAT THE PATIENT KEPT HEARING AN ALARM FROM THE DEVICE AND THAT THE PATIENT FEELS "JUMPING AND SHOCKING" FROM THE DEVICE. THE PATIENT'S MOTHER FURTHER REPORTED THAT THE DEVICE HAD BEEN MAKING NOISES AND THAT THE PATIENT HAD "DROP ATTACKS" AND THE DEVICE IS "SHOCKING HER" AND "STINGING HER". SHE ALSO NOTED BEEPING WAS HEARD FROM THE DEVICE "LIKE A HOUSE ALARM" AND BEGAN "IN CAR" AND WAS HAPPENING EVERY NIGHT. ALSO REPORTED WAS A VISIT TO PREVIOUS CARDIOLOGIST "POST CARDIAC ARREST DURING ABLATION". IT WAS REPORTED VIA COMPETITOR PAPERWORK THAT THE PATIENT WAS EXPERIENCING PAIN AND HEARING "BEEPING TONES". THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.
THE PATIENT'S MOTHER REPORTED THAT THE PATIENT KEPT HEARING AN ALARM FROM THE DEVICE AND THAT THE PATIENT FEELS "JUMPING AND SHOCKING" FROM THE DEVICE. THE PATIENT'S MOTHER FURTHER REPORTED THAT THE DEVICE HAD BEEN MAKING NOISES AND THAT THE PATIENT HAD "DROP ATTACKS" AND THE DEVICE IS "SHOCKING HER" AND "STINGING HER". SHE ALSO NOTED BEEPING WAS HEARD FROM THE DEVICE "LIKE A HOUSE ALARM" AND THAT IT BEGAN "IN CAR" AND THAT IT WAS HAPPENING EVERY NIGHT. ALSO WAS REPORTED WAS A VISIT TO PREVIOUS CARDIOLOGIST "POST CARDIAC ARREST" DURING ABLATION". THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
THE PATIENT'S MOTHER REPORTED THAT THE DEVICE SOUNDS LIKE IT HAS AN ALARM IN IT, AND GOES OFF AT DIFFERENT TIMES OF THE DAY. (B)(6) 2010, (B)(4): THE PATIENT'S MOTHER FURTHER REPORTED THAT THE PATIENT KEPT HEARING AN ALARM FROM THE DEVICE AND THAT THE PATIENT FEELS "JUMPING AND SHOCKING" FROM THE DEVICE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2010, (B)(4): THE PATIENT'S MOTHER FURTHER REPORTED THAT THE DEVICE HAD BEEN MAKING NOISES AND THAT THE PATIENT HAD "DROP ATTACKS" AND THE DEVICE IS "SHOCKING HER" AND "STINGING HER". SHE ALSO NOTED BEEPING WAS HEARD FROM THE DEVICE "LIKE A HOUSE ALARM" AND BEGAN "IN CAR" AND WAS HAPPENING EVERY NIGHT. ALSO REPORTED WAS A VISIT TO PREVIOUS CARDIOLOGIST "POST CARDIAC ARREST DURING ABLATION". IT WAS REPORTED VIA COMPETITOR PAPERWORK THAT THE PATIENT WAS EXPERIENCING PAIN AND HEARING "BEEPING TONES". THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA SR | ASKU | NVZ | MEDTRONIC MED REL, INC. | ADSR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 4968 IMPLANTABLE PACING LEAD| 4968 IMPLANTABLE PACING LEAD |