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

Model Number ADDR01

Device Problems Pacing Problem (1439); Battery Problem (2885)

Patient Problem Death (1802)

Event Date 07/15/2020

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 4968-35 lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient is deceased (unexpected passing).The implantable pulse generator (ipg) exhibited duel circuit error and software fix was loaded on to the ipg.The ipg also exhibited elective replacement indicator (eri) post death.This maybe due to high rv thresholds or possible body temperature/exposure in morgue setting colder temps.

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.

Event Description

It was further reported that the right ventricular (rv) lead exhibited acute lead failure.It was also reported that there was a lead warning in mid (b)(6) for rising impedance, and one week prior to death there was an acute impedance rise with evidence of likely ventricular tachycardia (vt) that resolved, with concerns that those were make-break potentials, and prior to the patient's death there was another acute impedance rise.When the device was interrogated post-mortem the rv lead exhibited high impedance.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.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: 10822359
• MDR Text Key: 215862361
• Report Number: 3004209178-2020-19735
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00643169708624
• UDI-Public: 00643169708624
• 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,Followup
• Report Date: 12/14/2020

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: 12/28/2018
• Device Model Number: ADDR01
• Device Catalogue Number: ADDR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/19/2020; 12/04/2020
• Supplement Dates FDA Received: 11/27/2020; 12/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 6 YR