MAUDE Adverse Event Report: MEDTRONIC, INC. SIGMA 100 S; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number SS103

Device Problems Premature Discharge of Battery (1057); Contamination (1120); Battery Problem (2885); Device Contaminated During Manufacture or Shipping (2969); Appropriate Term/Code Not Available (3191)

Patient Problems Syncope (1610); Arrhythmia (1721); Cardiac Arrest (1762); Fainting (1847)

Event Date 08/05/2018

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 experienced arrhythmia and asystole.It was also reported the patient was hospitalized.Evaluation of the implantable pulse generator (ipg) revealed the battery was exhausted.When the ipg was replaced, the physician suspected that the device had liquid substance, and it was suspected that poor sealing of pacemaker led to short circuit of internal battery which caused depletion.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

The device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Correction: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was hospitalized for syncope, at that time, the ipg was found to be completely depleted.It was suspected that poor sealing resulted in a short circuit in the battery.At the ipg explant , the physician suspected that the device had liquid substance.

• Brand Name: SIGMA 100 S
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 7826466
• MDR Text Key: 118554387
• Report Number: 2182208-2018-01559
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 2018-08-10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/09/2019

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: 05/28/2009
• Device Model Number: SS103
• Device Catalogue Number: SS103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 10/01/2018; 03/01/2019; 04/16/2019; 05/09/2019
• Supplement Dates FDA Received: 10/01/2018; 03/15/2019; 04/17/2019; 05/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2007
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR