MAUDE Adverse Event Report: SIENTRA INC SIENTRA SILICONE GEL BREAST IMPLANTS

Model Number 20621-XXXMP

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Muscle Weakness (1967); Twitching (2172); Neck Pain (2433); Cognitive Changes (2551); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

Sientra complaint #: (b)(4).At this time, the suspect device has not been returned for evaluation.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

Patient claim breast implant illness, symptoms: muscle spasms, muscle twitching, atrophy in shoulder, neck pain, brain fog, memory issues, and severe fatigue.There isn¿t an official medical diagnosis for breast implant illness.

Manufacturer Narrative

Sientra complaint (b)(4) device evaluation: d9, g3, g6, h2, h3, h6, h10 sientra received the suspected device from the customer and performed a failure analysis.The device was returned intact and functional with light yellowing.The device weighed 308.1 grams.No additional observations.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: SIENTRA SILICONE GEL BREAST IMPLANTS
• Type of Device: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA INC; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer (Section G): SIENTRA INC; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer Contact: denise dajles ; 8055628401
• MDR Report Key: 18484344
• MDR Text Key: 332558798
• Report Number: 1651189-2024-06191
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: 20621-XXXMP
• Device Catalogue Number: 20621-305MP
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/19/2023
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female