MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ADAPTA; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number ADDRL1

Device Problems Electrical /Electronic Property Problem (1198); Pacing Problem (1439); Pocket Stimulation (1463)

Patient Problems Muscle Stimulation (1412); Undesired Nerve Stimulation (1980); Pain (1994); Burning Sensation (2146)

Event Date 08/11/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient then experienced muscle stimulation, painful pocket stimulation and a burning sensation near the sight of the device after an accidental impact to the implantable pulse generator (ipg).The device was reported to have mode switched and exhibited a high-output.It was also noted that right ventricular (rv) lead exhibited high thresholds, intermittent non-capture and that a polarity switch had occurred.The device was explanted, the rv lead was capped and both were replaced.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.The battery indicator signifying that it is time for device replacement occurred after explant.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADAPTA
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8959894
• MDR Text Key: 156425294
• Report Number: 3004209178-2019-16920
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00613994222084
• UDI-Public: 00613994222084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2016
• Device Model Number: ADDRL1
• Device Catalogue Number: ADDRL1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 383059 LEAD, 5076-45 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR